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

Model Number URF-V

Device Problems Break (1069); False Device Output (1226); Peeled/Delaminated (1454); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.A leak test on the subject device was conducted, and air leak was found.When confirming the inside of the channel, the channel wall was turned up at the place of around 20mm from the distal end, and there was a pinhole.When removing the bending rubber, water was flooded at almost the same place as the channel pinhole.The manufacturing record of the device was reviewed without irregularity.The exact cause of the reported event could not be conclusively determined, but there is a possibility that the channel pinhole occurred due to the insertion and removal of the forceps, and water or a chemical solution was flooded through the pinhole, causing the ccd unit temporarily short-circuited.In addition, the channel pinhole may occur because the forceps was inserted and removed with the cup opened, or the endotherapy accessory was inserted or removed in the following conditions: with it scratched or deformed, or with excessive force applied while the endoscope was bended.

Event Description

To perform f-tul (a transurethral ureterolithotomy procedure), the subject device was connected to the video system center (otv-s190), but the video image was not displayed.Even when otv-s190 was restarted, the video image was not restored.Though a clinical engineer of the user facility inquired to olympus affiliated company, the cause was unknown, so the user facility replaced the subject device with another urf-v and completed the procedure.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: 5757438
• MDR Text Key: 48402662
• Report Number: 8010047-2016-00778
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/29/2016

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: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2013
• 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