FDA Adverse Event Malfunction Summary report: N

RADIAL JAW 3 BIOPSY FORCEPS

MDR report key: 1895144 · Received November 10, 2010

Report

Report Number: 3005099803-2010-04731
Event Type: Malfunction
Date Received: November 10, 2010
Date of Event: October 19, 2010
Report Date: October 20, 2010
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: FCL
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.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.

Description of Event or Problem · 1

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04730 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RADIAL JAW 3 BIOPSY FORCEPS WERE USED DURING A COLON BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE FORCEPS WERE CLOSED THE NEEDLE WAS FOUND TO BE PROTRUDING FROM THE JAWS. A SECOND RADIAL JAW 3 BIOPSY FORCEPS WAS OPENED, BUT EXHIBITED THE SAME BENT NEEDLE CONDITION WITH THE JAWS CLOSED. THE PROCEDURE WAS COMPLETED WITH A THIRD RADIAL JAW 3 BIOPSY FORCEPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

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	M00515891

Patients

Seq	Age	Sex	Outcome	Treatment
1