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

Model Number	OTV-S7H-1NA-10E
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the user facility report was confirmed.The evaluation results found a faulty cable unit.Olympus serviced the device with the required replacement part(s) and the unit passed functional testing.Olympus will continue to monitor complaints for this device.
Event or Problem Description
The user facility reported that the screen is black on the device.It was reported that this issue was discovered during preparation for use so there was no patient involvement.
Additional Manufacturer Narrative
The original equipment manufacturer (oem), performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.It is presumed that the image was not displayed because the cable was damaged by unexpected stress being applied to the cable due to user's handling." olympus will continue to monitor the field performance of this device.To mitigate device damage the instruction for use provides the following: never excessively bend, pull, twist, coil, squeeze or apply a crushing force to the camera cable.The camera cable could become damaged.While the camera head is attached to the endoscope, never attempt to lift the entire assembly by the camera cable.Doing so could damage the cable.".

• Brand Name: 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: 10616778
• Report Number: 8010047-2020-07093
• Device Sequence Number: 2793023
• Product Code: GCJ
• UDI-Device Identifier: 04953170141775
• UDI-Public: 04953170141775
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: Other
• Device Model Number: OTV-S7H-1NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1