FDA Adverse Event Malfunction Summary report: N

BRAVO

MDR report key: 4801913 · Received May 26, 2015

Report

Report Number: 9710107-2015-00134
Event Type: Malfunction
Date Received: May 26, 2015
Report Date: May 21, 2015
Manufacturer: GIVEN IMAGING LTD.
Product Code: FFT
PMA / PMN Number: K002028
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THIS CASE. THE INFORMATION WAS UPDATED IN THIS SUPPLEMENTAL. EVALUATION SUMMARY: ONE DELIVERY SYSTEM AND CAPSULE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE TROCAR NEEDLE WAS ADVANCED. THERE WERE NO SIGNS OF TISSUE AND BLOOD ON THE DEVICE. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE EMERGENCY RELEASE ON THE DELIVERY SYSTEM WAS NOT IMPLEMENTED. THE CAPSULE ELECTRODES WERE VISUALLY ACCEPTABLE. THE WIRE THAT HOLDS THE CAPSULE WAS COMPLETELY OFF AND THE FOAM GASKET WAS IN GOOD CONDITION. THE DELIVERY SYSTEM DID NOT HAVE ANY VISIBLE DAMAGE. AS THE PRODUCT WAS RECEIVED, THE DEVICE FUNCTIONED PER SPECIFICATION.

Description of Event or Problem · 1

CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO ATTACH. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE.

Description of Event or Problem · 1

A REPEAT PROCEDURE WAS NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL 15-20 MINUTES. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL. NO KNOWN ADVERSE EVENTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
341153	BRAVO	BRAVO PH CAPSULE	FFT	GIVEN IMAGING LTD.	FGS-0313	27262Q

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention