MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V"; URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The event date is (b)(6) 2021, when the adhesive was noted to be peeling on forceps cover.The reporter¿s contact information, occupation and health profession are unknown at this time.Further inspection of the returned device found bite marks on the insertion portion of the scope.The distal end cover was observed to be burnt.Moisture was noted in the scope¿s control unit and the switch box was corroded with short wires.The cause of the physical damage to the scope cannot be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.

Event Description

The customer was reported a leak at distal end of the scope.There was no patient involvement report.The device was returned for evaluation and found the scope leaking and protruding metal from the bending section rubber.This report is being submitted to address the protruding metal observed during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon of ¿bending tube metal braid deformed¿ (metal of the bending tube is sticking out) might have occurred due to the same reasons as other damages reported.However, it cannot be specifically determined if the reported event was caused by stress, handling, or other causes.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 03-nov-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: VIDEOSCOPE "URF-V"
• 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: 12958342
• MDR Text Key: 284178283
• Report Number: 8010047-2021-15714
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1