FDA Adverse Event Injury Summary report: N

RADIAL JAW 3 BIOPSY FORCEPS

MDR report key: 1813310 · Received August 24, 2010

Report

Report Number: 3005099803-2010-03644
Event Type: Injury
Date Received: August 24, 2010
Report Date: August 2, 2010
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: FCL
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL NUMBER AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE PRODUCT IS RECEIVED, UPON COMPLETION OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE CREATED A HEMATOMA WITHIN THE PATIENT. IT COULD NOT BE REPORTED IF ANY INTERVENTION WAS NEEDED TO TREAT THE HEMATOMA, NOR WHAT WAS DONE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 3 BIOPSY FORCEPS	FORCEPS, BIOPSY, NON-ELECTRIC	FCL	BOSTON SCIENTIFIC - COSTA RICA	UNK355

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other