MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPS

Additional Manufacturer Narrative

THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, HOWEVER CLINICAL AND PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS, OR OPERATOR TECHNIQUE ARE FACTORS THAT COULD HAVE CONTRIBUTED. FURTHERMORE, THE EVENT COULD BE RELATED TO THE DEVICE POTENTIALLY AS A RESULT OF CLIP MIS-FORMATION OR A FEEDING ISSUE. AS PER THE INSTRUCTIONS FOR USE, THE REPROCESSED MULTIPLE CLIP APPLIER IS INTENDED FOR USE ON TUBULAR STRUCTURES OR VESSELS WHEREVER A METAL LIGATING CLIP IS INDICATED. THE TISSUE BEING LIGATED SHOULD BE CONSISTENT WITH THE SIZE OF THE CLIP. THE STERILMED REPROCESSED MULTIPLE CLIP APPLIER IS AN AUTOMATIC LIGATING CLIP APPLIER THAT DELIVERS TITANIUM LIGATING CLIPS. THE MULTIPLE CLIP APPLIER IS SUPPLIED WITH A MINIMUM OF 10 CLIPS (PLEASE NOTE: THE CLIP APPLIER IS NOT PRELOADED WITH A CLIP IN THE BREACH) THAT INDIVIDUALLY ADVANCE AFTER EACH CLIP APPLICATION. THE INSTRUMENT AND CLIPS ARE DESIGNED TO OFFER A FAST, EFFICIENT MEANS OF LIGATION. THE CLIPS ARE APPLIED TO THE VESSEL OR OTHER TUBULAR STRUCTURES BY POSITIONING THE JAWS WITH THE CLIP AROUND THE VESSEL AND FULLY SQUEEZING THE HANDLES OF THE APPLIER. WHEN THE HANDLES ARE COMPLETELY RELEASED, A NEW CLIP IS AUTOMATICALLY ADVANCED INTO THE JAWS OF THE INSTRUMENT. AFTER THE LAST CLIPS IS USED, THE INSTRUMENT IS DESIGNED TO LOCKOUT, WHICH PREVENTS THE HANDLES FROM BEING SQUEEZED. REPROCESSED MULTIPLE CLIP APPLIERS HAVE BEEN CLEANED, EVALUATED FOR CONTINUED INTEGRITY, PACKAGED, AND STERILIZED FOR A SINGLE SUBSEQUENT USE. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE REPROCESSED MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM WITH LARGE CLIPS (ETHER320/UNKNOWN LOT #) AND ENCOUNTERED INCREASED BLEEDING INTRAOPERATIVELY AS THREE DIFFERENT CLIPS FELL OFF AFTER THEY WERE APPLIED. FURTHERMORE, IT WAS REPORTED THAT THE REFURBISHED CLIP APPLIER ONLY INCLUDED TEN CLIPS, AS OPPOSED TO THE ORIGINAL CLIP APPLIER WHICH CONTAINS 30 CLIPS. THE REPORTER STATES THAT CONSEQUENTLY THERE IS A DELAY IN CARE WHEN THE PHYSICIANS RUN OUT OF CLIPS MUCH SOONER THAN ANTICIPATED AS THE PATIENT CONTINUES TO BLEED WHILE ANOTHER APPLIER HAS TO BE OPENED. AS PER THE REPORT, THE ORIGINAL CLIP APPLIER DID NOT HAVE CLIPS FALL OFF THE TISSUE AND DID NOT NEED TO HAVE MULTIPLE APPLIERS OPENED THROUGHOUT THE CASE. AT THIS TIME, NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE INFORMATION PROVIDED, THE EVENT OF INCREASED BLEEDING WAS CAUSED AS THREE DIFFERENT CLIPS ¿FELL OFF¿ AFTER THEY WERE APPLIED DURING THE PROCEDURE. CLIP NOT HOLDING DURING THE PROCEDURE IS A REPORTABLE MALFUNCTION.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE REPROCESSED MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM WITH LARGE CLIPS (ETHER320/UNKNOWN LOT #) AND ENCOUNTERED INCREASED BLEEDING INTRAOPERATIVELY AS THREE DIFFERENT CLIPS FELL OFF AFTER THEY WERE APPLIED. FURTHERMORE, IT WAS REPORTED THAT THE REFURBISHED CLIP APPLIER ONLY INCLUDED TEN CLIPS, AS OPPOSED TO THE ORIGINAL CLIP APPLIER WHICH CONTAINS 30 CLIPS. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE REPROCESSED ETHER320 CLIP APPLIER IS DISTRIBUTED WITH AT LEAST 10 CLIPS WITHIN THE DEVICE. THE DEVICE HAS THE NUMBER ¿10¿ WRITTEN ON THE HANDLE NEXT TO THE 20 EMBOSSED ON THE HANDLE, WITH A LINE DRAWN THROUGH THE NUMBER 20 ON THE HANDLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).