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

Model Number	OTV-S7H-NA-12E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- address: (b)(6) hospital.The device was returned to olympus for evaluation and the customer's allegation was confirmed.In addition, device evaluation found flooded cable and loose scope mount.Based on investigation, the reported phenomenon was confirmed.The cause of the issue could not be identified by the information obtained from this complaint and the investigation results.For the additional findings, the cause of the issue could not be identified based on the information obtained from this complaint and the results of the investigation.A device history review revealed no issues that could have caused or contributed to the reported issue.Per instruction for use (if), it states: do not clean, disinfect, sterilize, or store this product with tweezers, forceps, or scalpels.There is a risk of puncturing the camera cable and damaging the electrical circuitry inside the product due to water leakage.Be very careful not to scratch the camera cable with sharp objects.Do not bump or drop this product.Water leakage may damage the electrical circuits inside the product.Do not drop the camera head or allow it to strike other objects.Strong impacts could damage the electrical circuits inside the camera head.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported "there was an electrical crack in the universal cord" of the subject device.There was no patient involvement on this reported event, no harm reported due to the event.
Additional Manufacturer Narrative
This report is being submitted to provide additional information received from the customer.
Event or Problem Description
It was reported "there was an electrical crack in the universal cord" of the subject device.The issue happened during reprocessing prior to an unspecified procedure.There was no patient involvement on this reported event, no harm reported due to the event.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18741708
• Report Number: 3002808148-2024-30846
• Device Sequence Number: 7233838
• Product Code: FET
• UDI-Device Identifier: 04953170141867
• UDI-Public: 04953170141867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2006
• 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