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
The device was returned to olympus for evaluation.The user report of "no image" was confirmed due to faulty charge coupled device unit.Cable unit was tested on a known-good charge coupled device unit however intermittent noise/ white streaks were exhibited in the image.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The high definition autoclavable camera head displayed intermittent noise/ white streaks in the image.No patient harm or injury occurred due to this malfunction.
Additional Manufacturer Narrative
Based on further file review the g3 aware date in the initial report is corrected to 4/28/2021.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely a failure of the ccd unit or a failure of the cable unit.Cable failure is likely due to user handling.The failure of the ccd unit is likely due to the deterioration of the material of the ccd sensor from ultraviolet rays.This issue is addressed in the instructions for use (ifu): "do not coil the camera cable with a diameter of less than 20 cm.The camera cable may be damaged.Never excessively pull the camera cable, but straighten it gradually when it is coiled.The camera cable could be damaged.Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable.The camera cable could be damaged.Do not use excessive force when wiping the external surfaces of the camera cable.The camera cable could be damaged.Never attempt to lift the entire assembly by the camera cable while the camera head is attached to the endoscope.The camera cable could be damaged.Never use a clamp or forceps to attach the camera cable to another object.The camera cable could be damaged.".

• 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: 11892985
• Report Number: 8010047-2021-06801
• Device Sequence Number: 14374123
• Product Code: GCJ
• UDI-Device Identifier: 04953170228865
• UDI-Public: 04953170228865
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 06/23/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 05/28/2021; 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1