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

Model Number HYF-V

Device Problem Mechanical Problem (1384)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.Inspection and testing found the forceps stopper was loose due to physical stress.In addition, movement was not smooth during angulation due to a broken control section, the insertion section was damaged, the forceps and cleaning brush got caught during insertion due to the channel being damaged, the cord and connector were damaged, the control body was damaged, there was insufficient light from the light guide lens, and the bending section was leaking.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported that the image was dark and the connector was broken.The intrauterine observation procedure was completed using the same device.The device was returned to an olympus service center for evaluation.During inspection and testing of the returned device, the forceps stopper was found to be loose.This report is being submitted for the malfunction found during evaluation (loose forceps stopper).There was no harm or user injury reported due to the event.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 24-feb-2022.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.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The cause of the suggested phenomenon was presumed to be stress or handling of the device.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: 13939405
• MDR Text Key: 288362032
• Report Number: 8010047-2022-05226
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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: Health Professional
• Device Model Number: HYF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1