COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO UNIVERSAL*65 12MM INSTR.W/4.8MM DLU; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number 173052 |
Device Problem
Failure to Form Staple (2579)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 09/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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To repair the internal herniation, one endouniversal stapler was used to close the meso, as usual during this intervention.Afterwards, the patient was found with an obstruction of the small intestines.At reoperation, surgeon discovered that this bowel obstruction was caused by one of the staples that was not totally closed, and the bowel was hooked on it.The current patient status is ok.Additional information has been requested but not yet received.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per additional information received, according to the reporter, to correct the patient's obstruction, relaparoscopy was performed two days post-op.The stapler was also removed, which grabbed a piece of mesentery because it was not fully closed.The staple line was incomplete in the initial procedure.The original intended procedure was closing internal hernia ports and a laparoscopic cholecystectomy.The last known patient status was good, fully recovered.
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