ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
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Model Number SXPP1B420 |
Device Problem
Positioning Failure (1158)
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Patient Problems
Fever (1858); Fistula (1862); Pain (1994); Tachycardia (2095); Ulcer (2274)
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Event Date 09/30/2021 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a surgical revision for duodenal diversion by jejunal anastomosis of the bypass in front of the presence of a relative stenosis scarring of the antrofundic junction on (b)(6) 2021 and a barbed suture was used.Post-op on (b)(6) 2021, the patient was discharged in front of a favorable development.On (b)(6) 2021, the patient is referred by her general practitioner for abdominal pain, fever and tachycardia.A scan was done in the emergency room, allowing visualization of a perforated stomach ulcer.The patient underwent treatment by laparotomy in the operating room.At the time of the intervention, it was found the releasing of the threads from the previous surgery.During the intervention, it was performed a gastric resection of the stomach excluded up to the pylorus, as well as sample to aim bacteriological and mycological, washing and setting place a drain next to the sutured fistula and feeding jejunostomy.It was opined by the surgeon that the thread was not be enough barbed which would have caused a probable release of the threads.The patient continued hospitalization in intensive care for seven days and was discharged to home on (b)(6) 2021 in the face of a favorable development.Additional information was requested.
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Manufacturer Narrative
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(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? other relevant patient history/concomitant medications? what is the patient's current status? lot number? trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ¿g/m.
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