FDA Adverse Event Malfunction Summary report: N

ENDO PATH

MDR report key: 90809 · Received May 8, 1997

Report

Report Number
90809
Event Type
Malfunction
Date Received
May 8, 1997
Date of Event
April 10, 1997
Report Date
April 28, 1997
Manufacturer
ETHICON ENDO-SURGERY, INC.
Product Code
GCJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

DURING LAP CHOLE - THE "O" RING FROM TROCAR FELL INTO THE ABDOMEN. DR. RETRIEVED "O" RING FROM PTS ABD. CAVITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENDO PATH DISPOSABLE SURGICAL TROCHAR GCJ ETHICON ENDO-SURGERY, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 39 YR