FDA Adverse Event Malfunction Summary report: N

ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

MDR report key: 99796 · Received June 17, 1997

Report

Report Number: 1527736-1997-01335
Event Type: Malfunction
Date Received: June 17, 1997
Report Date: June 17, 1997
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: GAG
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: INVALID DATA

Narratives

Additional Manufacturer Narrative · 1

FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A UNKNOWN. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVIC WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973200. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES A)YES,B)YES,C)YE, NOSE SHROUD CRACKED/BROKEN A)YES,B)YES,C)NO, STAPLES IN NOSE A)YES,B)YES,C)YE, STAPLES IN THE TRACK A)YES(16).B)YES(2, TRIGGER ENGAGED WITH PRECOCK A)YES,B)YES,C)YE. FUNCTIONAL TESTS & RESULTS: CYLCED INSTRUMENT A)YES,B)YES,C)YES. ANALYSIS CONCLUSION: BASED ON THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENTS A AND B JAMMED DUIRING SURGERY DUE TO A YIELDED CARTRIDGE NOSE WELD. INSTRUMENT C WAS FOUND TO B CONFORMING ITS REMIANING FOUR STAPLES FIRED AND FORMED PROPERLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE NOSE WELDS HAD YIELDED. CO REVIEWS EACH INCIDENT AS IT OCCURS IN A EFFORT TO CONTINUOUSLY IMPROVE THE PROUCTS AND PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED. THERE WAS NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH ENDOSCOPIC MULTIFEED STAPLER	ENDOSCOPIC STAPLER	GAG	ETHICON ENDO-SURGERY, INC.	NA	K46295

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other