FDA Adverse Event Malfunction Summary report: N

OLYMPUS

MDR report key: 285433 · Received July 7, 2000

Report

Report Number
285433
Event Type
Malfunction
Date Received
July 7, 2000
Date of Event
June 2, 2000
Report Date
June 6, 2000
Manufacturer
*
Product Code
HCZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

DURING A HYSTERECTEROSCOPY, WHILE ATTEMPTING TO REMOVE AN INTRAUTERINE DEVICE, THE JAWS OF THE GRASPER BROKE. HALF OF THE JAW WAS RETRIEVED AND HALF WAS NOT. PHYSICIAN MADE AWARE OF SITUATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OLYMPUS GRASPER A4695 HCZ * * *

Patients

Seq Age Sex Outcome Treatment
1 54 YR