FDA Adverse Event Injury Summary report: N

RADIAL JAW 4 BIOPSY FORCEPS

MDR report key: 1884110 · Received October 27, 2010

Report

Report Number: 3005099803-2010-04472
Event Type: Injury
Date Received: October 27, 2010
Report Date: October 7, 2010
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: FCL
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT ID, AGE, GENDER, AND WEIGHT ARE UNKNOWN. EVENT DATE IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A BIOPSY WAS TAKEN AND BLEEDING OCCURRED. HEMOSTATIC TREATMENT WAS USED TO STOP THE BLEED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE TYPE OF TREATMENT PERFORMED TO STOP THE BLEED AND THE CURRENT CONDITION OF THE PATIENT COULD NOT BE OBTAINED. HOWEVER, THE COMPLAINANT DID REPORT THAT THE PATIENT WAS HOSPITALIZED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RADIAL JAW 4 BIOPSY FORCEPS	FORCEPS, BIOPSY, NON-ELECTRIC	FCL	BOSTON SCIENTIFIC - COSTA RICA	M00513381

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R