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

Model Number	OTV-S7H-VA
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the issue was confirmed.The issue was due to a faulty cable unit.Additionally, a kink was found on the cable.There was also a crack on the video connector.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported by the customer, the autoclavable camera head presented a black screen.The picture was black.The issue was found during preparation for use for a procedure.No patient harm reported.No additional information was available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.Cable breakage may have interfered with a stable communication to the processor, resulting in no image.The shipment record for the device was reviewed and no abnormalities were found.The cable breakage may be attributed to user's handling.The instruction for use (ifu) states the following guidelines: ·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: 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: 12459753
• Report Number: 8010047-2021-11618
• Device Sequence Number: 1245305
• Product Code: GCJ
• UDI-Device Identifier: 04953170179822
• UDI-Public: 04953170179822
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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-VA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1