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

Model Number	CH-S190-XZ-Q
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.During the evaluation, the reported issue was unable to be duplicated.A faulty cable unit was found causing an intermittent discoloration and noise on the image.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.
Event or Problem Description
A surgical supply coordinator at a user facility reported that the image did not appear and that the camera focus was not working while using a camera head.The problem was first noticed before a procedure.There was no delay in the procedure in which the subject device was used.The intended procedure was completed.No patient involvement or injury was reported.No additional information has been obtained.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.As a result of the physical inspection and functional testing of the device, olympus was not able to conclusively determine why the cable unit failed.The device was repaired and returned to customer.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The instructions for use states: never excessively bend, pull, twist, coil, squeeze, or crush the camera cable, which could damage the camera cable.

• Brand Name: HD AUTOCLAVABLE CAMERA HEAD
• Common Device Name: AUTOCLAVABLE 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: 11280531
• Report Number: 8010047-2021-02238
• Device Sequence Number: 16341123
• Product Code: FET
• UDI-Device Identifier: 04953170310782
• UDI-Public: 04953170310782
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: CH-S190-XZ-Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1