MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection, service repair noted the following findings: device inspection noted watertightness is not maintained due to the falling off of the curved rubber.The insertion part serpentine is crushed, the curved rubber has fallen off.The forceps stopper found scraped.Furthermore, the following findings during inspection were noted on the device: there are scratches on the operation part, grip, angle lever, ud (up/down) plate, video cable, video connector, light guide connector, ud angle fixing lever due to external factors.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer sent a repair request reported with an issue of tip air leak.The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.Device evaluation found the forceps plug mouthpiece is scraped and a-rubber has fallen off.

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.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress or the user's handling of the device.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Additional information.

• 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: 14660805
• MDR Text Key: 301239688
• Report Number: 8010047-2022-09894
• Device Sequence Number: 1
• Product Code: HIH
• 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,Followup
• Report Date: 08/25/2022

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: Other
• Device Model Number: HYF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 08/14/2022
• Supplement Dates FDA Received: 08/01/2022; 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• 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