FDA Adverse Event Malfunction Summary report: N

ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

MDR report key: 112234 · Received August 7, 1997

Report

Report Number: 1527736-1997-01931
Event Type: Malfunction
Date Received: August 7, 1997
Report Date: July 11, 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: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAD COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974387. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: STAPLES IN NOSE, YES(1 TWISTED). STAPLES IN THE TRACK, TRIGGER ENGAGED WITH PRECOCK, FUNCTIONAL TESTS & RESULTS: CYLCED INSTRUMENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED WHY IT WAS REPORTED "STAPLES WOULD NOT ADVANCE" DURING SURGERY. THE INSTRUMENT WAS RECEIVED WITH A TWISTED STAPLE IN THE NOSE AND A SEVERELY BENT TUBE (WHICH OCCURRED DURING SURGERY). NO FUNCTIONAL ANALYSIS COULD BE PERFORMED DUE TO THE BENT TUBE. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS AND PROCESSES.

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 STAPLES WOULD NOT ADVANCE. 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	K46L47

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other