SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number 72203967S |
Device Problem
No Display/Image (1183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported that, during surgery, the "camera head" had rf interference issues, the image drop and the screen was black.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.No further information is available.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 received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation was performed in conjunction with an rf generator and the reported malfunction was not observed.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the instructions for use found the following warning: ¿to minimize any reciprocal interference from or to the system, use a dedicated power outlet during any rf treatment or investigation.¿ please note the reported event may be related to a concomitant device.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.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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