MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.The reported phenomenon was reproduced.The evaluation revealed that there were perforation in the a-rubber, burned bending tube, snapped angulation wire, and perforation in the channel in up-side of the tube at 18 mm and 30 mm from the distal end.The interior of the control body was checked and the angulation wire was found intact.Based on the user facility's comment and the above evaluation result, the subject phenomenon is considered to be attributable to the snapped up-angulation wire due to the inadvertently irradiated laser.The manufacturing record of the subject device was reviewed with no abnormality possibly related to the subject phenomenon.

Event Description

Olympus was informed that the user became aware that angulation was unable when the user inserted the subject device into the ureter for f-tul (flexible transurethral lithotomy).The treatment was aborted due to the availability of a spare device, and the procedure was concluded by placing a stent.The user facility commented that the possible cause might be irradiating laser inadvertently while the laser device was still in the scope.It is unclear when the laser was inadvertently irradiated.There was no patient injury reported.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5359623
• MDR Text Key: 35622445
• Report Number: 8010047-2016-00091
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K#:K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: URF-V
• Device Catalogue Number: URF-V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1