FDA Adverse Event Malfunction Summary report: N

BRAVO

MDR report key: 4218909 · Received September 30, 2014

Report

Report Number: 9710107-2014-00204
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: IN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM AND CAPSULE WERE RETURNED TO MEDTRONIC FOR EVALUATION. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE TROCAR NEEDLE WAS ADVANCED. THE DELIVERY SYSTEM WAS BENT AND THE PLUNGER WAS 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 EXCEPT THE PLUNGER WAS ROTATED MORE THAN 1/8 OF A TURN. 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 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 A ONE YEAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
607244	BRAVO	BRAVO PH CAPSULE	FFT	IVEN IMAGING LTD.	FGS-0313	24516Q

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention