ETHICON ENDO-SURGERY, LLC. ENDOSUTURE SYSTEM ASSISTANT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number SW110 |
Device Problem
Component Falling (1105)
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Patient Problem
Foreign body, removal of (2365)
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Event Date 02/09/2015 |
Event Type
malfunction
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Event Description
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It was reported that during a laparoscopic gastric sleeve procedure, upon deploying the knot, three little pieces fell off of the suture cartridge.All pieces were retrieved from the patient and saved for analysis.Case completed with another device of the same product code.
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Manufacturer Narrative
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(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The analysis results found that a sw110 device was returned disassembled; the valve tube, the cartridge base and the cartridge plate were returned separated.Each component was inspected and physical evidence associated with user error was found as scratches were noted to be on both sides of the cartridge plate and it was observed to be slightly bent; the damages found on the cartridge base were scratches on one of the sides and the stake was noted to be damaged and bent.The scratches in the cartridge plate and base were approximately at the same location, which suggests that a foreign object was introduced between the plate and the body, and the bent condition suggests the foreign object was used to force the plate out.
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