FDA Adverse Event Injury Summary report: N

RADIAL JAW BIOPSY FORCEPS

MDR report key: 7292 · Received December 27, 1993

Report

Report Number: 1219544-1993-00055
Event Type: Injury
Date Received: December 27, 1993
Report Date: November 2, 1993
Manufacturer: SYMBIOSIS CORPORATION
Product Code: KGE
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: AZ, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

THE DISTRIBUTOR BECAME AWARE ON OCTOBER 18, 1993 OF AN INCIDENT INVOLVING A RADIAL JAW BIOPSY FORCEP. THE ORIGINAL PROCEDURE, N UPPER ENDO ROUTINE BIOPSY, WAS COMPLETED WITHOUT INCIDENT. THE PATIENT RETURNED TO THE HOSPITAL WITH A BLEED AT THE BIOPSY SITE. THE LESION WAS SCLEROSED AND CAU TERIZED, BUT CONTINUED TO OOZE. THE PATIENT WAS DISCHARGED. TWO DAYS LATER THE PATIENT RETURNED WITH RECURRENT BLEEDING AND UNDERWENT A SUCCESSFUL SURGICAL REPAIR. NO MALFUNCTION OF THE PRODUCT WAS DETERMINED. THE PHYSICIAN STATED THE PRODUCT FUNCTIONED APPROPRIATELY DURING USE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RADIAL JAW BIOPSY FORCEPS	BIOPSY FORCEPS	KGE	SYMBIOSIS CORPORATION		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Required Intervention