Model Number MAJ-2254 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
Event Type
malfunction
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Event Description
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As reported for this event by the customer, during a therapeutic laparoscopic colectomy procedure, part of the 4k image was flickering due to the disconnection of the device.The procedure was completed with another similar device.There is no harm or adverse impact to the patient.
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Manufacturer Narrative
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The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that there was no red image yielded.When connected and operated according to the instruction manual, there are no other abnormalities than this.There was no abnormality in the appearance of the device.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
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Event Description
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Addendum jul 26, 2022: the event occurred during preparation for use prior to the procedure.There is no patient involvement.The device was replaced with another similar device for the set up, and the intended procedure was completed with no delay.
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Manufacturer Narrative
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Additional information has been received from the customer.This supplemental report is being submitted to provide this information.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A definitive root cause for this issue was not established.However, it is probable that the image problem occurred because the device¿s cable was broken.The cable was also partially bent and showed signs of the coating/adhesive peeling.These damages may have resulted from a mishandling of the device.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿do not bend, pull, or twist the power cord.Equipment damage including separation of the power plug and disconnection of the cord wire as well as a fire or an electric shock may result.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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