MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. AUTOCLAVABLE CAMERA HEAD

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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that while using the autoclavable camera head, the customer observed completely dead / dark image.There were no reports of patient harm or impact associated with the event.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation of no image was confirmed.The investigation revealed no endoscopic image (black screen only) and a defective coupler unit.The coupler was too loose and out of axis.Additionally, the cable unit and the coupler unit were faulty and were replaced.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.Based on the results of the investigation it is likely the lack of image was caused by a faulty cable.It is likely the cable is damaged due to user handling.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿never excessively bend, pull, twist, coil, squeeze, or crush the camera cable.Doing so could damage the camera cable.¿ olympus will continue to monitor field performance for this device.
Event or Problem Description
Follow up was conducted with the customer and the following procedural/patient information was reported.Concomitant medical products were reported (d)(10).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the customer.Mfr report # 3002808148-2023-01685.Patient identifier: (b)(6).Additional information provided by the customer: follow up was conducted with the customer and the following procedural/patient information was reported.Concomitant medical products were reported (d)(10) -cv-190, sn (b)(6) & clv-190, sn (b)(6).

• Brand Name: AUTOCLAVABLE CAMERA HEAD
• Common Device Name: CAMERA HEAD
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16429528
• Report Number: 3002808148-2023-01685
• Device Sequence Number: 5297410
• Product Code: GCJ
• UDI-Device Identifier: 04953170141805
• UDI-Public: 04953170141805
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K043275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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: 02/09/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 04/14/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/07/2023; 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2006
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLV-190 SN (B)(6); CV-190, SN (B)(6)
• Patient Sex: Unknown