MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Break (1069)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found detachment of the insertion tube, watertightness of the insertion tube was not maintained, the bending angle was insufficient, forceps could not be inserted smoothly into the forceps channel, liquid leakage was found in the light guide bundle, the flexible tube of the insertion section was crushed, corrosion due to water leakage was found in the operation part, the neutral position was out of standard due to axial misalignment of the operating part, liquid leakage was observed in the grip, liquid leakage was found on the up/down plate, paint floating was found on the up/down plate, liquid leakage was found in the universal cord, and the universal cord was collapsed.Scratches were found on the grip, the universal cord, the rotating mechanism, the angle lever, the video cable, the video connector, the light guide connector, and the video connector case.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the uretero-reno videoscope had the coating torn and the metal coil exposed.Inspection and testing of the returned device found that the corrugated tube was falling off.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the information supplied by the legal manufacturer.Please refer to the following sections for the new information: event date, relevant tests/laboratory data, including dates, concomitant products.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to stress, handling or other issues.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15521464
• MDR Text Key: 306176032
• Report Number: 3002808148-2022-02669
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 09/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2011
• 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
• Treatment: CLV-S190, SERIAL NO.(B)(4).; OTV-S190, SERIAL NO.(B)(4).