FDA Adverse Event Malfunction Summary report: N

RADIAL JAW 4 BIOPSY FORCEPS

MDR report key: 2031903 · Received March 28, 2011

Report

Report Number: 3005099803-2011-01007
Event Type: Malfunction
Date Received: March 28, 2011
Report Date: March 8, 2011
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: FCL
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. HOWEVER, THE PATIENT WAS REPORTED TO OVER THE (B)(6). THE EXACT EVENT DATE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PROCEDURE TOOK PLACE SOMETIME BETWEEN THE FEBRUARY (B)(6) 2011. 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. (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 AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE DEVICE WAS TESTED AND THE JAWS WOULD NOT CLOSE COMPLETELY. DURING THE PROCEDURE THE PHYSICIAN REPORTED THAT THE RADIAL JAWS TOOK BAD BITES AND BAD SPECIMENS. NO PATIENT BLEEDING WAS REPORTED. THE CASE WAS COMPLETED WITH THIS 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 4 BIOPSY FORCEPS	FORCEPS, BIOPSY, NON-ELECTRIC	FCL	BOSTON SCIENTIFIC - COSTA RICA	M00513412

Patients

Seq	Age	Sex	Outcome	Treatment
1