SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number 72204925 |
Device Problem
Contamination /Decontamination Problem (2895)
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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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(b)(4).
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Event Description
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It was reported that the "light guide orange (5mm x 12ft)" had a dark substance around the connection point.The customer discussed the instructions for use and confirmed they using correctly 270°, 4 minutes, 30 cool down.No case reported; therefore, there was no patient involvement.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).D4: expiration date and lot number added.H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed a dark spot between the tubing and ferrule at the source end and corrosion on the bundle tip at the instrument end.Analysis of the customer provided images revealed brown residue between the tubing and the ferrule of various light guides and debris.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with a component failure.Factors that could have contributed to the reported event include chemicals or sterilization methods used for reprocessing.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.
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Search Alerts/Recalls
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