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 not returned to olympus medical systems corp.(omsc) for evaluation.The manufacturing record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.Omsc presumed that the phenomenon occurred because some external force was applied.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on (b)(6) 2021, it was found that the coating of the insertion tube had been partially peeled off due to deterioration.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: 12716140
• MDR Text Key: 281407589
• Report Number: 8010047-2021-13780
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 10/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1