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)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date is (b)(6) 2021 when the ccd damage was noted.Further inspection of the unit found severe kinks and knots in the cable.The cause of the cable and ccd damage cannot be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.
Event or Problem Description
The customer reported that during set-up the unit displayed a blurry image.There was no patient involvement.The unit was returned for evaluation and found no image was displayed due to faulty charge-coupled device (ccd) which is considered to be a reportable malfunction.
Additional Manufacturer Narrative
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.Review of the product shipment record, found no problem with the device.Based on the results of the investigation, the damage of the cable may be attributed to the user¿s handling.As stated on the ifu (instruction for use) the user manual states: 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: 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: 12333658
• Report Number: 8010047-2021-10362
• Device Sequence Number: 4980648
• Product Code: GCJ
• UDI-Device Identifier: 04953170228865
• UDI-Public: 04953170228865
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 07/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1