Model Number 72203967 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/1901 |
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 the set up before the surgery, the camera head screen was not showing any image.No patient injuries or delay reported.Unknown how the surgery was completed.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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Internal complaint reference (b)(4).The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection did not identify any issues.A functional evaluation was performed on the returned device and found a dark screen display with no visible image.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with an electrical component failure.Factors which could have contributed to the reported event, include internal damage to the cord or connector.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that during the set up, the camera head screen was not showing any image.There was no delay and it is unknown if a back-up device was available.There was no patient involvement.
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Search Alerts/Recalls
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