MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HD AUTOCLAVABLE CAMERA HEAD

Model Number	OTV-S7PROH-HD-10Q
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device has not been returned for evaluation, we are unable to determine a root cause for the reported event.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.
Event or Problem Description
A user facility reported an image problem every time they move the part that plugs into the processor.Sometimes there is no image and lines on the screen.No patient involvement or injury was reported.No additional information has been obtained.
Additional Manufacturer Narrative
The investigation has been completed.A faulty ccd unit was causing the grainy image.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: damage to the board and the ccd unit which was caused by some strong impact applied to the device while the user handled it.Corrosion of /dirt on/ adhesion of foreign objects to the electrical contacts of the video connector; or failure in connection to the video connector." the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the event might have been caused due to improper handling by the user/ accidental failure.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Common Device Name: CAMERA HEAD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10516386
• Report Number: 8010047-2020-06393
• Device Sequence Number: 2410445
• Product Code: FET
• UDI-Device Identifier: 04953170252945
• UDI-Public: 04953170252945
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: OTV-S7PROH-HD-10Q
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1