TA PREMIUM

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. A VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED: NO ABNORMALITIES WERE OBSERVED WITH THE INSTRUMENT. THE CLINICAL LOADING UNIT WAS RECEIVED. FUNCTIONALLY, THE LOADING UNIT WAS RESET, RELOADED WITH STAPLES AND LOADED INTO THE CLINICAL INSTRUMENT. THE LOADING UNIT WAS APPLIED TO TEST MEDIA WITH PROPER STAPLE FORMATION. THE PIN WAS PROPERLY ALIGNED. NO ABNORMALITIES WERE OBSERVED WITH THE INSTRUMENT. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT OPEN HEMICOLECTOMY PROCEDURE, WHILE TRANSECTING THE RIGHT COLON, THE TIP OF THE INSTRUMENT DID NOT SEEM TO BE ALIGNING PROPERLY AND THE STAPLE LINE DIDN'T FEEL CORRECT WHEN FIRING OR LOOK CORRECT POST FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE. THE SURGEON HAD TO FREE UP MORE BOWEL TO REDO THE ANASTOMOSIS EXTENDING THE PROCEDURE BY 45 MINUTES.