FDA Adverse Event Injury Summary report: N

RADIAL JAW 4 BIOPSY FORCEPS

MDR report key: 1222070 · Received November 6, 2008

Report

Report Number: 3005099803-2008-06131
Event Type: Injury
Date Received: November 6, 2008
Date of Event: October 5, 2008
Report Date: October 7, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FCL
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

SECTION A: AGE AND WEIGHT - UNKNOWN. DURING ESOPHAGOGASTRODUODENOSCOPY (EGD) OF DUODENUM, A RADIAL JAW 4 BIOPSY FORCEP WAS USED. THE PHYSICIAN SUSPECTED THAT THE PATIENT HAD CELIAC DISEASE. THE TISSUE BIOPSIES OF THE DUODENUM WERE TAKEN TO CONFIRM THE DIAGNOSIS. THREE DAYS OF THE POST-PROCEDURE, THE PATIENT CONTACTED THE PHYSICIAN WITH CONCERN OF BLACK STOOLS. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO BE SCOPED AGAIN. THE BLEEDING FROM THE BIOPSY SIGHT IN THE DUODENUM WHICH HAD A VISIBLE VESSEL WAS NOTED. THE SITES WERE INJECTED AND CAUTERY WAS USED TO STOP THE BLEEDING. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RADIAL JAW 4 BIOPSY FORCEPS		FCL	BOSTON SCIENTIFIC CORPORATION	M00513374	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention