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  

Event Description

The customer reported that the forceps got caught during insertion when using the hyf-v visera hysterovideoscope.There was no reported patient harm or impact due to this event.During device evaluation at olympus, the forceps plug cap was found to be scraped off.This mdr is being submitted to capture the reportable malfunction found during device evaluation.

Manufacturer Narrative

The device was evaluated at olympus and the customer's allegation was confirmed.The device evaluation found the bending angle was insufficient due to elongation of the angle wire, the forceps plug cap was scraped off, the universal code was collapsed, the display of the light guide connector was incorrect and there were scratches on the universal cord and video cable.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

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 17 years since the subject device was manufactured.Based on the results of the investigation, the abrasion of the forceps likely occurred due to the same cause as other breaks, but it was not possible to determine whether the abrasion was due to stress or handling or other factors.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15470684
• MDR Text Key: 306260081
• Report Number: 3002808148-2022-02322
• 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: K022445
• 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: 11/11/2022

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: 08/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2007
• 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