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

Model Number URF-V2

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 metal part of the bending section of the subject device was punctured and exposed from its bending rubber. It was found the damages of the bending rubber and the metal part. Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported phenomenon could not be conclusively determined. However, based upon the information from sorc omsc surmised that the reported phenomenon was attributed to the external factor such as contact to sharp instrument. If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed during the incoming inspection for repair at olympus service operation repair center (sorc), that it was found the metal part of the bending section of the subject device was punctured and exposed from its bending rubber. The subject device had been returned from the user because the subject device had the pin hole at the distal end. 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12566396
• MDR Text Key: 275144483
• Report Number: 8010047-2021-12592
• 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

• 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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown