VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING

Description of Event or Problem

IT WAS REPORTED THAT DURING A THERAPEUTIC HYSTEROSCOPY, THE LOOP OF THE SINGLE USE BIPOLAR ENDOSCOPIC ELECTROSURGICAL ELECTRODE BROKE INSIDE THE PATIENT. THE LOOP, OR WHAT APPEARED TO BE PART OF IT, WAS RETRIEVED. FOLLOWING COMPLETION OF THE PROCEDURE, AN X-RAY WAS PERFORMED TO ENSURE THAT NO FRAGMENTS REMAINED, AND WHAT APPEARED TO BE A SMALL RESIDUAL PIECE OF THE LOOP WAS OBSERVED. AN MRI WAS BEING CONSIDERED TO CONFIRM. AT THE TIME OF THE REPORT, THE PATIENT DID NOT HAVE ANY ISSUES RELATED TO THE EVENT.

Additional Manufacturer Narrative

THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.