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

Model Number URF-V2

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation of the device found a huge leak on the biopsy unit.The ¿a-rubber¿ glue was found cracked and the ¿a-rubber¿ was observed with a cut and was leaking.The bending section was damaged and the control knob was observed with a clicking sound.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings, the reported issue was confirmed.The device damage was attributed to physical damage and is likely attributed to user maintenance issue and or device handling issue.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.

Event Description

It was reported that during reprocessing, the device was found leaking.No other further details were provided.No patient involvement on this report, no user harm or impact was reported.

Manufacturer Narrative

This supplemental report is being submitted to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10336306
• MDR Text Key: 200848966
• Report Number: 8010047-2020-04922
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1