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

Model Number	OTV-S7H-NA-10E
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device was returned to olympus for evaluation.The customer¿s reported issue was confirmed as the no image malfunction was attributed to a defective/faulty charged coupled device unit.Additionally, there are knots and kinks on the cable unit.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.
Event or Problem Description
Olympus was informed via service inquiry that the customer autoclavable camera head had a no image malfunction, the image is black.The event was found during an unspecified event.No death, injury or harm was reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The information entered into initial reporter health professional, initial reporter occupation, and report source of the initial medwatch report was inadvertently entered in error.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the loss of image was due to an unstable electrical connection from the half-disconnected cable.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information received from the initial reporter noting the reported event (no image) was found during an unknown diagnostic procedure.The procedure was completed using a similar device without delay.There was no patient harm on consequence reported as a result of this event.

• Brand Name: AUTOCLAVABLE CAMERA HEAD
• Common Device Name: ENDOSCOPE VIDEO CAMERA
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14483667
• Report Number: 8010047-2022-08779
• Device Sequence Number: 5160525
• Product Code: GCJ
• UDI-Device Identifier: 04953170141805
• UDI-Public: 04953170141805
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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 Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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-NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown