FDA Adverse Event Malfunction Summary report: N

RICHARD WOLF

MDR report key: 1117 · Received August 18, 1992

Report

Report Number: 1117
Event Type: Malfunction
Date Received: August 18, 1992
Date of Event: July 20, 1992
Report Date: July 21, 1992
Manufacturer: RICHARD WOLF
Product Code: FXQ
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

THE RICHARD WOLF C MOUNT LENS WAS SOAKED FOR ONE HOUR PRIOR TO ITS USE IN COLDSPOR. IT WAS THEN RINSED WITH STERILE WATER AND TOWEL DRIED BEFORE BEING HOOKED TO SCOPE FOR PROCEDURE. DURING THE PROCEDURE, THE C MOUNT LENS FOGGED DUE TO MOISTURE. THIS NECESSITATED A DECISION TO STOP THE LAPAROSCOPIC PROCEDURE AND SWITCH TO AN OPEN CHOLECYSTECTOMY. THE PATIENT TOLERATED THE PROCEDURE WELLDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER, UNANTICIPATED, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RICHARD WOLF	C MOUNT LENS/CAMERA	FXQ	RICHARD WOLF	5261.27	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other