MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA HYSTEROVIDEOSCOPE

Model Number HYF-V

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition, other issues found included: an insufficient curvature angle, discoloration of curved rubber, poor forceps insertion, poor insertion of cleaning brush, lens detached from imaging unit, light guide (lg) bundle broken, uneven lighting, water tightness of control unit and water tightness failure in the curved section, corrosion of actuator, leakage of grip liquid, leakage of up/down (ud) plate liquid, liquid leakage from lg bundle and scratches were found on multiple device components due to handling problem.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the visera hysterovideoscope had buckling of the insertion part.The device was returned for evaluation.During the device evaluation, the metal was found to be protruding from the perforation in the bending section cover due to the breakage of the curved tube.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

Updated: h6, h10 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.Based on the results of the investigation, a definitive root cause of the metal angle wire protruding from the bending section could not be determined, however, the issue was likely the result of observed damage to the bending tube due to user handling/mishandling.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA HYSTEROVIDEOSCOPE
• Type of Device: HYSTEROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18325116
• MDR Text Key: 330848731
• Report Number: 3002808148-2023-14249
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04953170340185
• UDI-Public: 04953170340185
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K221557
• 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
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• 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