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

Model Number URF-V

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to sorc but has not been returned to omsc. Sorc checked the subject device for evaluation. It was confirmed that the insertion tube of the subject device was peeled off more than 4mm due to the deterioration. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. It could not be identified the cause of the reported phenomenon. However based on the report of sorc, omsc surmised there was the possibility this phenomenon was attributed to deterioration of the insertion part serpentine tube of the subject device. In addition, it has been confirmed that this phenomenon does not occur due to product or manufacturing, and that there is no problem with safety and there are no multiple occurrences. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed that during the incoming inspection at olympus service operation repair center (sorc), it was found that the insertion tube of the subject device was peeled off more than 4mm. The occurrence date of the event is unknown. There was no report of patient injury associated with the 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
• MDR Report Key: 12566388
• MDR Text Key: 280928656
• Report Number: 8010047-2021-12590
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No