FDA Adverse Event Malfunction Summary report: N

ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

MDR report key: 82257 · Received February 20, 1997

Report

Report Number: 1527736-1997-00066
Event Type: Malfunction
Date Received: February 20, 1997
Report Date: February 20, 1997
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: GAG
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

H6; CODE 400: DAMAGED FIRING MECHANISM. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE 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 THE FIRING MECHANSIM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMRPROVE CO'S PRODUCTS.

Description of Event or Problem · 1

DURING AN L A V H, THE INSTRUMENT DID NOT WORK PROPERLY. NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP" 1/24/97 0950 LEFT MESSAGE AND 800# FOR MD TO CALL BACK. 1/027/97 NNCL SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER	ENDOSCOPIC LINEAR CUTTER	GAG	ETHICON ENDO-SURGERY, INC.	NA	J43A22

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other