MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA HYSTEROVIDEOSCOPE

Model Number HYF-V

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

This device was returned for the issue a pin hole in the distal end rubber coating (a-rubber).There is no harm to any patient or persons.Upon evaluation of the returned device, it was observed that there is rattling in the forceps plug mouthpiece.This medwatch is being submitted for the reportable issue of the rattling in the forceps plug mouthpiece observed during deice evaluation.

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that there is rattling in the forceps plug mouthpiece.This is indicative of stress experienced by the device.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 29-mar-2022.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct 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 13 years since the subject device was manufactured.Based on the results of the investigation, rattling in the forceps plug mouthpiece may have been caused by the same factors as the other damages; however, we could not determine if rattling was attributed to stress or handling of the device, or some other factors.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA HYSTEROVIDEOSCOPE
• Type of Device: HYSTEROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14172616
• MDR Text Key: 290549324
• Report Number: 8010047-2022-06819
• 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: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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: 03/29/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2008
• 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