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

Model Number HYF-V

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, that during an unspecified procedure the visera hysterovideoscope insertion section was damaged.There were no reports of patient harm associated with this event.During evaluation of the returned device, the evaluation found that the forcep stopper cap was scraping.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer's complaint was not confirmed.In addition to the findings reported in description of event or problem, the following non-reportable malfunctions were identified: water tightness lost, due to pinhole on connecting tube; adhesive on rubber chipped; angulation lever does not move smoothly, due to damage; and forceps cannot be smoothly inserted, due to damage on channel tube.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.

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.Based on the results of the investigation, a root cause could not be determined.However, it is likely that the cause of the phenomenon is mishandling of the user or that wear of ordinary use led to breakage of the device.The following is included in the device ifu: "do not bend, hit, drag, twist or drop the tip of the endoscope, insertion section, bending operation section, video cable and the light guide connector with strong force for preventing failure, breakage of the tip of the endoscope, flexible part, bending part, operation part, universal cord, and device and drop of parts." 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: 16518920
• MDR Text Key: 311570374
• Report Number: 3002808148-2023-02329
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04953170411564
• UDI-Public: 04953170411564
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYF-V
• Device Catalogue Number: N6007430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2007
• 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