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

Model Number HYF-V

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection service repair noted the image was observed blurred due to damaged objective lens.The objects lens fall off and noted damaged.The customer reported issue of "out of focus" was able to be confirmed.Furthermore, the following findings during inspection were noted on the device: the flexible tube of the insertion section found crushed due to external factors.Bending angle out of standards.The forceps cannot be inserted smoothly due to crushed forceps channel.The adhesive part of the lighting lens noted peeling off.Detachment of the curved rubber adhesive part observed.Scratches are found on the operation part due to external factors.Scratches are found on the switch box due to external factors.Scratches are found on the grip due to external factors.There are scratches on the angle lever due to external factors.The angle lever is discolored due to handling.Scratches are found on the up/down (ud) plate due to external factors.Scratches are found on the universal cord due to external factors.Scratches are found on the video cable due to external factors.Wrinkles are observed in the video cable due to external factors.The coating of the video cable has come off due to external factors.Scratches are found on the video connector due to external factors.Scratches are found on the lg connector due to external factors.Scratches are found on the video connector case due to external factors.Dirt on the video connector case that is difficult to remove due to handling was noted.The video connector case found cracked due to external factors.There are scratches on the ud angle fixing lever (sp) due to external factors.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of "out of focus".The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.Device evaluation found the objective lens was damaged (fall off).This report is being submitted for damaged objective lens (fall off ) found on device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to d5.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the detached objective lens was due to stress or user 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15459893
• MDR Text Key: 306319027
• Report Number: 3002808148-2022-02229
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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: 08/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2007
• 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