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

Model Number	OTV-S7H-NA
Medical Device Problem Codes	Image Orientation Incorrect (1305); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had an issue of "image distortion when moving" , repair was requested.There was no patient impact, no harm reported due to the event.
Additional Manufacturer Narrative
E1- address; customer facility/hospital address: (b)(6).The device was returned and the investigation is ongoing.This report will be supplemented following investigation completion or if additional information is provided by the user facility.
Event or Problem Description
It was reported the device had an issue of "image distortion when moving" , repair was requested.There was no patient impact, no harm reported due to the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide device evaluation information supplied by the manufacturer.The device was not returned to olympus for evaluation and therefore the customer's allegation was not confirmed.Device history record (dhr) review: a dhr was reviewed and no issues that could have caused or contributed to the reported issue were found.Instructions for use (ifu): if the endoscopic image disappears unexpectedly during an examination, or if the freeze cannot be released, immediately stop using the endoscope and remove it from the patient according to the warnings in "chapter 4: instructions for use.Continued use under such conditions may injure the patient, cause bleeding or perforation.The following must be strictly observed the endoscopic image may disappear unexpectedly during the examination or the freeze may not be released.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.Connect the video connector to the otv-s7v (visera digital processor) when it is sufficiently dry, including the electrical contacts.Wet connection may cause malfunction.If the camera cable is curled up, do not pull it forcibly, but straighten it gradually.There is a possibility that the camera cable will break.Do not apply excessive bending, pulling, twisting, crushing, or other force to the camera cable.Doing so may cause the camera cable to break.When wiping the outer surface of the camera cable, do not squeeze the camera cable strongly.Doing so may cause the camera cable to break.Hold the camera head, not the camera cable, while operating the endoscope.There is a possibility that the camera cable may break.Do not secure the camera cable using a pean or similar object.There is a possibility that the camera cable may break.Olympus will continue to monitor the field performance of this device.

• 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: 18505980
• Report Number: 3002808148-2024-30164
• Device Sequence Number: 7801882
• Product Code: FET
• UDI-Device Identifier: 04953170141744
• UDI-Public: 04953170141744
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K043275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2014
• 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