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

Model Number	OTV-S7H-1NA-10E
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the cause of the reported phenomenon could not be determined at this time.This report will be supplemented accordingly following investigations.
Event or Problem Description
Intermittent picture, the picture cuts out and comes back when cable is being adjusted was reported.The issue occurred during preparation for use.There was no patient involvement, no user injury reported due to the event.
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 and information gathered, the phenomenon occurs when the cable is adjusted, partial disconnection of the cable is considered to be the cause.Review of the product shipment record found no abnormality in the device.The partial disconnection of the cable is considered to be caused by the user's handling.It is concluded that the phenomenon can be prevented by the following , as stated in the ifu (instruction for use) 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.Olympus will continue to monitor complaints for this device.

• 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: 11879917
• Report Number: 8010047-2021-06726
• Device Sequence Number: 13780464
• Product Code: GCJ
• UDI-Device Identifier: 04953170141775
• UDI-Public: 04953170141775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/01/2021

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-S7H-1NA-10E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1