FDA Adverse Event Malfunction Summary report: N

ENDOPATH DISPOSABLE SURGICAL TROCAR

MDR report key: 90375 · Received May 9, 1997

Report

Report Number: 1527736-1997-00899
Event Type: Malfunction
Date Received: May 9, 1997
Report Date: May 8, 1997
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: GCJ
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FACILITY EXPERIENCED AN EVENT WITH ENDOPATH DISPOSABLE SURGICAL TROCAR WHILE PERFORMING A LAP APPENDECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 972614-1. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: DESUFFLATION LEVER CONDITION, CONFORMING; INNER GASKET CONDITION, CONFORMING; OUTER GASKET CONDITION, NONCONFORMING; SLEEVE CONDITION, NONCONFORMING AND STOPCOCK CONDITION, CLOSED. FUNCTIONAL TESTS & RESULTS: FLAPPER DOOR FUNCTIONAL, CONFORMING. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO AND VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE REPORTED "OUTER GASKET TORE WHILE INTRODUCING A EZ35B." NO CONCLUSION COULD BE REACHED AS TO HOW THE GASKETS ON THE INSTRUMENTS HAD BECOME TORN. CO REVIEWS EACH INCIDENCE AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS AND PROCESSES.

Description of Event or Problem · 1

THE DEVICES WERE USED DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE OUTER GASKETS TORE WHEN INTRODUCING A EZ35B. THERE WERE NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH DISPOSABLE SURGICAL TROCAR	TROCAR	GCJ	ETHICON ENDO-SURGERY, INC.	NA	J42K4D

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other