FDA Adverse Event Malfunction Summary report: N

DISPOSABLE 14MM PERFORATOR WITH HUDSON END

MDR report key: 8890 · Received July 22, 1994

Report

Report Number: 8890
Event Type: Malfunction
Date Received: July 22, 1994
Date of Event: December 22, 1992
Report Date: January 12, 1993
Manufacturer: CODMAN & SHURTLEFF INC.
Product Code: HGE
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PERFORATOR WAS CHECKED BY THE SCRUB NURSE AND BY THE SURGEON, PRIOR TO USE ON THE PATIENT. THE SKULL PERFORATOR WAS THEN USED ON THE PATIENT AND FAILED TO STOP CUTTING, PENETRATING THE DURA. THE AREA WAS REPAIRED WITH SUTURES. NO FURTHER COMPLICATIONS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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: A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		DISPOSABLE 14MM PERFORATOR WITH HUDSON END	HGE	CODMAN & SHURTLEFF INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other