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Model Number 72203967S |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device noted residue on the connector contacts.Functional evaluation revealed that there was noisy image and image loss when the connector is moved.The complaint has been confirmed.The instructions for use (ifu), provided with the device, contain the following warnings and precautionary measures related to proper use of the device, including but not limited to: the product must be cleaned and sterilized before every subsequent use; use only neutral ph cleaners to decontaminate the camera head.Non-neutral ph cleaners may cause residue buildup, which may cause interference in the video output.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that the screen of the camera head was showing purple queue.It is unknown when the issue was discovered, how the procedure was finished, and if a delay occurred.However, no patient injuries were reported.Results of investigation have concluded that this unit had loss of image which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Search Alerts/Recalls
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