RADIAL JAW 4 BIOPSY FORCEPS

Report

Report Number: 3005099803-2008-03824
Event Type: Injury
Date Received: August 22, 2008
Date of Event: July 23, 2008
Report Date: July 24, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: KNW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS FOR THE REPORTED LOT NUMBER. THE JUNE 2008, 15-MONTH RADIAL JAW 4 BIOPSY FORCEPS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY PROCEDURE PERFORMED ON THE DAY BEFORE (ADULT FEMALE PT; AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO TAKE A BIOPSY OF A SHORT BARRETT'S SEGMENT. BLEEDING WAS NOTED WHEN THE FIRST SAMPLE WAS ACQUIRED AND ADDITIONAL BLEEDING OCCURRED AFTER THE SECOND SAMPLE WAS ACQUIRED. IT WAS FURTHER REPORTED THAT POST PROCEDURE, THE PT WAS ADMITTED TO THE ER AND GIVEN ONE UNIT OF BLOOD. REPORTEDLY, A RESOLUTION HEMOSTASIS CLIP WAS PLACED AT THE BLEED SITE. THERE WERE NO REPORTED COMPLICATIONS AFTER THE CLIP WAS PLACED. AT THE CONCLUSION OF THE EVENT, THE PATIENT'S CONDITION WAS REPORTED TO BE "DOING FINE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RADIAL JAW 4 BIOPSY FORCEPS		KNW	BOSTON SCIENTIFIC CORPORATION	M00513372	11626355

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	PLAVIX (DOSAGE UNKNOWN)