JOHNSON AND JOHNSON PROFESSIONAL, INC. AFI/AFI 5MMX10FT LO PROFL; FIBEROPTIC ILLUMINATOR FOR ENDOSCOPE
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Catalog Number 24-3074 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burn, Thermal (2530)
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Event Date 02/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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Udi: lot number unknown; gtin unavailable, product made prior to compliance date.Upon completion of the investigation, a follow up report will be filed.
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Event Description
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Patient underwent extensive revision at site of prior right breast reconstruction and repair of 2 ventral hernias.A lighted retractor, used to illuminate the surgical site, was placed on patient's abdomen when not in use.It was reported that the handle of the fiber optic cable was emitting heat when off, and that it caused a thermal injury.
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Manufacturer Narrative
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The customer was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.Device not available.
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