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

Model Number	A10-T1
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, as noted, the unit had undergone insufficient reprocessing due to biological material having been found in the air/water leakage area.Additionally, physical damage was noted on the subject device, as well as a imaging focusing problem - confirming the user's report.If additional information becomes available following the device evaluation, a supplemental report will be filed.
Event or Problem Description
The customer originally returned her olympus video adapter due to a focusing issue.During the device evaluation, it was discovered that the subject device had undergone insufficient reprocessing as biological foreign material was found in the air/water way.This report is being submitted to capture the insufficient reprocessing found during the device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported image that was out of focus.Water invasion and corrosion were noted inside the device.The cause of the water invasion was unknown.A review of the device history record was not performed because the lot number of the subject device was unknown.The investigation did not establish a root cause for the reported image problem.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14550712
• Report Number: 8010047-2022-09143
• Device Sequence Number: 4794236
• Product Code: KNR
• UDI-Device Identifier: 04953170023392
• UDI-Public: 04953170023392
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: A10-T1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown