FDA Adverse Event Malfunction Summary report: N

BRAVO

MDR report key: 4218920 · Received September 30, 2014

Report

Report Number: 9710107-2014-00198
Event Type: Malfunction
Date Received: September 30, 2014
Report Date: September 28, 2014
Manufacturer: IVEN IMAGING LTD.
Product Code: FFT
PMA / PMN Number: K002028
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE CAPSULE WAS NOT RETURNED FOR INVESTIGATION. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE EMERGENCY RELEASE ON THE DELIVERY SYSTEM WAS NOT IMPLEMENTED. 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. THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THIS CASE. THE INFORMATION WAS UPDATED IN THIS SUPPLEMENTAL.

Description of Event or Problem · 1

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

Description of Event or Problem · 1

A REPEAT PROCEDURE WAS NOT NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. INTERVENTION WAS NOT REQUIRED. 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. THE DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR THREE YEARS. LUBRICANT WAS NOT USED TO FACILITATE CAPSULE PLACEMENT. NO KNOWN ADVERSE EVENTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
607517	BRAVO	BRAVO PH CAPSULE	FFT	IVEN IMAGING LTD.	FGS-0313	25197Q

Patients

Seq	Age	Sex	Outcome	Treatment
1