FDA Adverse Event Malfunction Summary report: N

ENDOPATH ENDOSCOPIC LINEAR CUTTER

MDR report key: 100020 · Received June 20, 1997

Report

Report Number
1527736-1997-01361
Event Type
Malfunction
Date Received
June 20, 1997
Manufacturer
ETHICON ENDO-SURGERY, INC.
Product Code
GAG
Removal / Correction Number
NA
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973145. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, FIRED; CARTRIDGE CONDITION, 1/4 FIRED AND CARTRIDGE RETURN BATCH NUMBER, K00P98. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, BROKEN; CONDITION OF SHORT RACK, GOOD AND CONDITION OF YOKE, GOOD. ANALYSIS CONCLUSION: BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA K4638C

Patients

Seq Age Sex Outcome Treatment
1 *