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

Model Number	OTV-S7H-NA
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and the investigation is ongoing.Follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the camera head had a crack, wire was cut.There were no reports of patient harm or involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide legal manufacturer¿s final investigation.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation also found folding stopper breakage on the head side, corrosion of electrical contacts, image failure due to cable damage, heavy switch operation, discoloration of the main body, and scratches on the switch.Based on the results of the investigation, a definitive root cause cannot be identified.A labeling review was conducted and it was confirmed that the risk/hazard was described in the ifu for the above issues.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus, the camera head had a crack, wire was cut.There were no reports of patient harm or involvement.

• 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 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18556909
• Report Number: 3002808148-2024-30361
• Device Sequence Number: 7859158
• Product Code: FET
• UDI-Device Identifier: 04953170141744
• UDI-Public: 04953170141744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/25/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2006
• 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
• Patient Sex: Unknown