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

Model Number URF-V2

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the information from sorc, there was the possibility that the reported phenomenon was attributed to the angulation with the excessive force while the bending section was locked, or the twisting of the insertion section with the excessive force, and so on.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp, (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc), it was found that the bending section cover of the subject device had been torn and the broken internal metal part had been sticking out from the inside of bending section cover of the subject device.There was no report of patient injury associated with this event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11285315
• MDR Text Key: 239441941
• Report Number: 8010047-2021-02282
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1