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
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Pain (1994); Peritonitis (2252); Not Applicable (3189)
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Event Date 08/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint (b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: the diagnosis and indication for the index surgical procedure?- total gastrectomy.On what tissue was the suture used?- the suture was used for esophagojejunostomy.It was reported that upon reoperation it was found that the suture had ¿become loose¿.What tissue dehisced? - the location is where spiral was used.Please provide return date, tracking number.- the device has been received and will be shipped.Please confirm that ¿1¿ device was involved in the reported event.- the reported quantity of the product involved is 1.What is the patient current status? - the patient is in the hospital under control in icu.The following information was requested, but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? was the anastomosis closure a single or multi-layer closure? did the operating surgeon observe any suture deficiency or anomaly before, during, after suture placement? other relevant patient history/concomitant medications.
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Event Description
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It was reported that the patient underwent a total gastrectomy on (b)(6) 2020 and the barbed suture was used for esophagojejunostomy by continuous suturing, common hole closure during overlap.On (b)(6) 2020, the patient complained of abdominal pain.A reoperation was performed on (b)(6) 2020.It was observed that the barbed suture had become loose and major leakage had occurred, causing panperitonitis near the anastomosis site.It was reported that the patient experienced a wound dehiscence at the location where barbed suture was used.The patient is currently in the icu due to serious condition.The surgeon opined that the cause of this leakage and panperitonitis was the product since the suture had become completely loose.The surgeon mentioned no other contributing factors.
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Manufacturer Narrative
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Date sent to the fda: 11/06/2020.Additional h6 patient codes: 1994.A manufacturing record evaluation was performed for the finished device pbj798, and no non-conformances were identified.Additional h3 summary: one open box with two unopened samples of product was received for analysis.Representative samples were examined for visual defects on the packets and no defects were found on the packages.The packets were opened and during the visual inspection the needles/sutures were correctly placed on the winding former.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were observed.The devices performed without any difficulties noted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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