FDA Adverse Event Malfunction Summary report: N

LITHOCLAST ULTRASOUND PROBE

MDR report key: 1326158 · Received February 26, 2009

Report

Report Number: 3005099803-2008-04132
Event Type: Malfunction
Date Received: February 26, 2009
Date of Event: May 9, 2007
Report Date: May 9, 2007
Manufacturer: BOSTON SCIENTIFIC CORPORATION-SPENCER
Product Code: FFK
PMA / PMN Number: K973788
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO INFORMATION AVAILABLE FROM USER FACILITY. THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RECEIVED BY THIS MANUFACTURER. AN EVALUATION HAS NOT BEEN PERFORMED; THEREFORE A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ABOUT 20 MINUTES INTO A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, THEY GOT AN ERROR CODE ON THE UNIT. WHEN THE PROBE WAS EXAMINED, IT APPEARED TO HAVE A CRACK ABOUT 2/3 OF THE WAY DOWN, TOWARD THE DISTAL END. A WOLF ULTRASOUND DEVICE WAS USED TO COMPLETE THE PROCEDURE, WITH NO COMPLICATIONS TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LITHOCLAST ULTRASOUND PROBE	LITHOTRIPTOR, ELECTRO-HYDRAULIC	FFK	BOSTON SCIENTIFIC CORPORATION-SPENCER	M0068407150

Patients

Seq	Age	Sex	Outcome	Treatment
1