MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEO ADAPTER

Model Number	AR-T12E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4).Olympus (b)(4) checked the subject device and found that the reported phenomenon was duplicated.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, it was found that the stopper and pin had been missing.The user completed the procedure with the subject device.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The reported phenomenon could occurred due to an external force when attaching the device to the endoscope while the lock ring knob of the device was not fully rotated.The instruction for use describes "when loosening the endoscope lock knob, take care to ensure that this is not unscrewed too far, as it may damage the endoscope lock knob.".

• Brand Name: VIDEO ADAPTER
• Common Device Name: VIDEO ADAPTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12082377
• Report Number: 8010047-2021-08119
• Device Sequence Number: 3870691
• Product Code: GCJ
• UDI-Device Identifier: 04953170023804
• UDI-Public: 04953170023804
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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
• Operator of Device: No Information
• Device Model Number: AR-T12E
• Device Lot Number: 68R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1