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

Model Number HYF-V

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

It was reported that the hysterovideoscope had a broken insertion part.There was no report of patient harm.The device was returned, evaluated, and it was found that there was rattling in the forceps plug mouthpiece.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

E1: establishment name: (b)(6).(noting due to character limit).The device was returned to olympus for evaluation of the reported issue.It was found that the connecting tube had a dent.In addition to the rattling in the forceps plug mouthpiece, other evaluation findings are as follows: the adhesive on the bending section cover was chipped; the connecting tube coating was peeling; there was an abnormal sound made due to damage on the angulation lever; the channel cleaning brush could not be inserted smoothly due to damage on the channel tube; the light guide lens was discolored; the universal cord had a dent; and there were scratches on the bending section cover, the control unit, the scope cover, the switch box, the video connector case, the video connector, the light guide connector, the light guide cover glass, the protector of the video cable section, the video cable, the universal cord, and the grip.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the events could not be determined.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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17597566
• MDR Text Key: 322479287
• Report Number: 3002808148-2023-08748
• 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
• Report Date: 08/22/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• 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