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

Model Number	OTV-S7PROH-HD-12Q
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection found no image due to faulty ccd (charge coupled device) unit.In addition, the device was observed to be equipped with a non ¿olympus cable.Based on evaluation findings the reported issue was confirmed.The failure found was due to faulty ccd unit causing no image.Additionally, unit was found with non-olympus cable device.If additional information becomes available this report will be supplemented accordingly investigations.
Event or Problem Description
During preparation for use the device was found with no image.The camera when plugged in would not get an image.There was no patient involvement, no user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, it is probable that the ccd failed due to the non-standard current flowing through the cable of the other company used by the customer.The cable was of a different voltage than the original one.As stated on the ifu (instruction for use), the user manual states: do not improperly repair or modify.Never disassemble or modify by anyone other than those approved by olympus.In addition, disassembling, modifying or repairing the product may result in injury to the human body or damage to the equipment, and the function cannot be ensured.Olympus will continue to monitor complaints for this device.

• 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: 11440180
• Report Number: 8010047-2021-03452
• Device Sequence Number: 3618106
• Product Code: GCJ
• UDI-Device Identifier: 04953170228865
• UDI-Public: 04953170228865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: Health Professional
• Device Model Number: OTV-S7PROH-HD-12Q
• Device Catalogue Number: OTV-S7PROH-HD-12Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1