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

Model Number HYF-V

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at olympus and the customer's allegation was confirmed.The device evaluation found the distal sheath was detached/missing and due to a cut distal sheath end, water tightness was lost.Additionally, the device evaluation revealed the connecting tube had a dent and discoloration, the video cable had a wrinkle and dirty, the universal cord was dirty and the distal end was shaved.Scratches were also found on the following device components: video connector and case, light guide connector, video cable, universal cord, lock engagement lever, connecting tube, angulation lever, grip, switch box and control unit.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that while using the visera hysterovideoscope, the distal sheath end was found to be cut.There was no patient harm associated with the event.During device evaluation at olympus the distal sheath was found to be detached.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Event Description

The intended procedure was provided as gynecological outpatient hysteroscopy.The intended procedure was not completed and was rescheduled.No delay or patient harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer and to provide additional information based on the legal manufacturer's investigation.Mfr report # 3002808148 - 2023 - 00500.Patient identifier: (b)(6).Additional information provided by the customer: please see updates to b5, b3 and d10.The event date was provided.The intended procedure was provided as gynecological outpatient hysteroscopy.The intended procedure was not completed and was rescheduled.Additional devices in use were provided.No delay or patient harm was reported.Additional information based on the legal manufacturer's investigation: please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon was attributed due to stress of repeated use, external factors, or handling.The root cause of this event was unable to be identified.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: 16188158
• MDR Text Key: 309131409
• Report Number: 3002808148-2023-00500
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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: 12/18/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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: OTV¿SI 7556773