SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number 72204354 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during an arthroscopic procedure, the light source suddenly went off.After troubleshooting was conducted, the entire system was turned off including the "lens integrated system" and started it all up again.After this, it worked fine and the procedure was successfully completed without significant delay using a back-up device.No patient injuries 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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Internal complaint reference (b)(4).
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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 and found residue on the light engine glass rod assembly.The reported malfunction was not observed during functional evaluation.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.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event potentially include a mismatched or damp light cable.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 complaint history review concluded this was a repeat issue.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.
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Search Alerts/Recalls
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