ETHICON INC. ENDOLOOP LIGATURE WITH COATED VICRYL; LAPROSCOPE, GENERAL & PLASTIC SURGERY
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Catalog Number EJ10G03 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported that the patient underwent an unknown procedure on unknown date and suture was used.During the procedure, before opening the product, the nurse held the packet up to the light to inspect it and saw pinholes in the packaging material.Another like suture was pulled and used to complete the procedure.There was no patient involvement and no adverse consequences reported.Additional information has been requested.
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Manufacturer Narrative
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The actual device was returned for evaluation.Visual examination revealed holes at the completely opened foils, top and bottom foils, and the holes were seemingly caused by handling of the customer during opening.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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