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

Model Number HYF-V

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The exact cause has been under investigation, therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that it was found green/gray liquid came out from near the control body of the subject device just after the manual cleaning after the first unspecified diagnostic procedure.The user canceled the second unspecified diagnostic procedure what was scheduled.The user also reported that there was no abnormal during the manual cleaning of the subject device before the procedure, and during the manual cleaning of the subject device after the procedure.Also the green and gray liquids were colors which the user never had not seen.There was no report of patient injury associated with this event.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for the evaluation.Omsc checked and confirmed followings; visual inspection result; it was not found the green or gray liquid from/around the subject device which the user has found.It was found the holes on the bending rubber of the subject device.It was found the scratch on the adhesive part of the bending rubber section of the subject device.Air leak inspection.It was found the leak from the bending rubber of the subject device.Function and image inspection.It was found no abnormality for the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However based on the user report and the evaluation, omsc surmised there was the possibility this phenomenon was attributed to the holes on the bending rubber section which made the liquid come into the subject device because the holes were found at the omsc inspection.Since there were no reports that the holes had found at reprocessing before/after procedure, the holes might have occurred at the handling.Also since it was found the scratch on the adhesive part of the bending rubber section, the bending rubber might had been applied some external force.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 11033349
• MDR Text Key: 222319690
• Report Number: 8010047-2020-10620
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K022445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1