FDA Adverse Event Malfunction Summary report: N

GRASPER AND AMPULLA DILATOR

MDR report key: 25341 · Received July 18, 1994

Report

Report Number: 1418479-1994-09078
Event Type: Malfunction
Date Received: July 18, 1994
Report Date: June 28, 1994
Manufacturer: R. WOLF, GMBH
Product Problem: Yes
Report Source: Distributor report
Reporter Location: GM
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

PER WRITTEN NOTICE FROM OUR PARENT CO., THE ABOVE CAPTIONED INSTRUMENT WAS RECEIVED AT THEIR FACILITY FOR INSPECTION. A JAW ON THE INSTRUMENT WAS BROKEN OFF. NO FURTHER INFORMATION IS 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	GRASPER AND AMPULLA DILATOR	SAME		R. WOLF, GMBH	8383.48	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other