FDA Adverse Event Malfunction Summary report: N

URETERO-RENO VIDEOSCOPE

MDR report key: 4926205 · Received July 16, 2015

Report

Report Number: 8010047-2015-00597
Event Type: Malfunction
Date Received: July 16, 2015
Date of Event: June 18, 2015
Report Date: June 26, 2015
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Product Code: FGB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. BASED UPON THE EVALUATION OF THE SUBJECT BY OMSC, THE PHENOMENON DUPLICATED AND THE ANGULATION CONTROL DID NOT OPERATE IN THE DOWN SIDE. THE LEAKAGE TEST WAS PERFORMED AND THE SUBJECT DEVICE FAILED DUE TO PINHOLES AT THE OPENING OF THE INSTRUMENT CHANNEL AND THE BENDING COVER. FURTHERMORE, INSIDE THE PINHOLE OF BENDING COVER, IT WAS CONFIRMED THAT THE ANGULATION WIRE WAS BROKEN AND BURNED. THE LIGHT GUIDE BUNDLE AND A PART OF BENDING STRUCTURE CLOSE TO THE WIRE BREAKAGE POINT HAD MELTING MARKS. THE MANUFACTURING HISTORY WAS REVIEWED WITH NO IRREGULARITIES RELATED TO THIS PROBLEM NOTED. BASED ON THE FINDINGS, THIS EVENT POSSIBLY DERIVED FROM THE USER'S IMPROPER HANDLING SUCH AS ACTIVATING LASER EMISSION WITH OUT THE EDGE OF A LASER PROBE STICKING OUT OF THE SUBJECT DEVICE.

Description of Event or Problem · 1

OLYMPUS MEDICAL SYSTEM CORP. (OMSC) WAS INFORMED THAT DURING THE PNL PROCEDURE, A STONE WAS AT THE FRONT OF THE SUBJECT DEVICE, BUT THE USER FACILITY COULD NOT PERFORM ANGULATION CONTROL AND RETRIEVED THE SUBJECT DEVICE FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. THE USER FELT LIKE A WIRE SNAPPED, BEFORE THE ANGULATION CONTROL BECAME DISABLED. THERE WAS NO PATIENT HARM REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
463450	URETERO-RENO VIDEOSCOPE	URETERO-RENO VIDEOSCOPE	FGB	OLYMPUS MEDICAL SYSTEMS CORPORATION	URF-V

Patients

Seq	Age	Sex	Outcome	Treatment
1