FDA Adverse Event Malfunction Summary report: N

RIGID GRASPING FORCEPS

MDR report key: 25347 · Received July 18, 1994

Report

Report Number: 1418479-1994-09084
Event Type: Malfunction
Date Received: July 18, 1994
Report Date: June 29, 1994
Manufacturer: R. WOLF, GMBH
Product Code: JEK
Product Problem: Yes
Report Source: Distributor report
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

PER WRITTEN NOTICE FROM OUR PARENT CO..., THE FORCEPS WERE RECEIVED FOR REPAIR FROM THE FRENCH SUBSIDIARY. A BROKEN JAW WAS MISSING ON THE INSTRUMENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RIGID GRASPING FORCEPS	SAME	JEK	R. WOLF, GMBH	8952.65	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other