FDA Adverse Event Injury Summary report: N

RADIAL JAW 4 BIOPSY FORCEPS

MDR report key: 1941242 · Received December 29, 2010

Report

Report Number: 3005099803-2010-05330
Event Type: Injury
Date Received: December 29, 2010
Report Date: December 7, 2010
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA
Product Code: FCL
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THE EXACT AGE OF THE PATIENT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT IS OVER 18 YEARS OF AGE. 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 DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE COLONOSCOPY PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO ISSUES WERE NOTED. ADDITIONALLY, THE DEVICE WAS INSPECTED PRIOR TO USE, NO ANOMALIES WERE FOUND, AND THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. THE NEXT DAY THE PATIENT EXPERIENCED ABDOMINAL PAIN. THE PATIENT WENT TO THE HOSPITAL, AN EX-RAY WAS TAKEN AND FREE AIR WAS NOTICED IN THE COLON, DUE TO PERFORATED CECUM. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. NO ADDITIONAL TREATMENT WAS REQUIRED TO TREAT THE PERFORATION. THE PATIENT'S CONDITION CURRENT CONDITION WAS REPORTED TO BE OKAY.

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			Hospitalization