Ethicon Harmonic Scalpel Lawsuit Alleges Fractured Device Left Metal Fragment in Pelvis

Surgeons allegedly completed the procedure despite knowing a scalpel fragment was missing, with later imaging revealing a retained metal piece in the patient’s pelvis.

A Texas woman has filed a lawsuit alleging that an Ethicon Harmonic Scalpel fractured during a routine hysterectomy at a Department of Veterans Affairs hospital, leaving a metal fragment embedded in her pelvis that remains there today.

The complaint (PDF) was filed by Sage Phoenix, formerly known as Jeanette Phoenix, in the U.S. District Court for the Northern District of Texas on March 2. It names the United States of America, under the Federal Tort Claims Act, and Ethicon US LLC as defendants.

The Ethicon Harmonic Scalpel is a surgical instrument that uses ultrasonic energy, rather than electrical current, to cut tissue and seal blood vessels during open and minimally invasive procedures. The device creates rapid vibrations at the metal tip, allowing surgeons to cut tissue and control bleeding with limited heat spread. It is commonly used in gynecologic, colorectal, urologic and general surgeries.

However, if a surgical instrument malfunctions, it can create serious risks for patients. Potential complications may include damage to surrounding tissue, failure to properly seal blood vessels, or in certain cases fracturing of metal components that could remain inside a patient’s body and require additional treatment or corrective surgery.

In her lawsuit, Phoenix indicates she underwent a laparoscopic hysterectomy with bilateral salpingectomy and cystourethroscopy at the Dallas VA Medical Center on April 1, 2024. The procedure was performed by Dr. Mark Griffo, a VA-employed obstetrician-gynecologist.

During the operation, Dr. Griffo used an Ethicon Harmonic Scalpel, model HP054, for bladder dissection. While in use, the scalpel allegedly fractured, and a portion of its metal active electrode broke off inside Phoenix’s abdominal cavity.

After noticing the instrument appeared shorter, the surgeon summoned an Ethicon representative into the operating room, who confirmed the device had fractured and indicated he would address the issue with the manufacturer, according to the complaint.

The lawsuit states the surgeon was unable to locate the broken metal fragment during the procedure. Although staff performed imaging on the removed uterus to determine whether the fragment was present, no intraoperative imaging was conducted on Phoenix’s abdomen before the surgical site was closed.

The complaint alleges the surgical site was closed despite knowledge that a portion of the scalpel remained inside her body.

A CT scan conducted on June 11, 2024, reportedly confirmed the presence of a retained metal fragment in Phoenix’s pelvis, located behind her bladder.

While the operative note estimated the fragment to be approximately 2 millimeters long, the CT report allegedly measured the object at approximately 6 mm by 4 mm by 4 mm, suggesting it was significantly larger than originally believed. The scan also identified an umbilical hernia. The complaint states it is currently unknown whether the hernia is related to the retained scalpel fragment.

Phoenix alleges she continues to experience persistent pelvic pain in the area where the metal fragment remains. She also claims ongoing emotional distress and anxiety over the possibility that the sharp object could migrate and damage internal organs.

According to the lawsuit, physicians have advised that removal of the fragment would require additional surgery, which carries significant risks to her internal organs and future recovery.

“The United States’ negligence was the direct and proximate cause of Ms. Phoenix’s injuries. But for Defendant’s failure to locate and remove the fractured scalpel fragment prior to closure of the surgical site, the metal fragment would not have remained embedded in Ms. Phoenix’s pelvic region.”

— Sage Phoenix v. United States of America et al

The complaint raises allegations of medical malpractice against the United States, as well as strict products liability — manufacturing defect and negligent manufacturing against Ethicon.

Phoenix is seeking compensation for past and future medical expenses, physical pain, emotional distress and the potential need for corrective surgery.

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