SMITH & NEPHEW, INC. CAMERA CONTROL UNIT HIGH DEF 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number 72201919 |
Device Problems
Poor Quality Image (1408); Overheating of Device (1437); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that during a knee surgery, there was smoke coming out of the camera control unit and it was getting hot.The image was flashing.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of the customer-supplied video was performed and observed image flashing on a video monitor.A review of the customer-supplied photograph was performed and observed the device serial number to be (b)(6).The complaint of flashing image was confirmed and the root cause was associated with component failure.The complaints of smoke and getting hot could not be confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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