MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number SXPP1B420

Device Problem Positioning Problem (3009)

Patient Problems Peritonitis (2252); Not Applicable (3189)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device pdr685, and no non-conformances were identified.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.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure , woman, slim, (b)(6) years.The diagnosis and indication for the index surgical procedure? right colon cancer on what tissue was the suture placed? anastomotic breach between small intestine and large intestine.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? normal.Was stratafix suture used to close common channel? yes or was stapler used to close.Common channel? mechanical anastomosis was performed.Was the stratafix suture used for oversewing? no.Please clarify ¿peritonitis¿; did the patient experience peritonitis? no the patient experienced abdomen filled with bowel content.If applicable, will product be returned, return date, tracking information no.Does the surgeon believe that a suture deficiency led to post-op complications?what is the patient current status? ok."the surgeon doubted that the reload fo 45mm used to anastomize was short and caused an occlusion.When the feces brought the tissue to maximum tension, the suture gave way, causing feces to escape into the abdomen.They had to re-operate the patient and repackage a new anastomosis." the following information was requested but unavailable: what tissue dehisced?.

Event Description

It was reported that the patient underwent right laparoscopic hemicolectomy on (b)(6) 2019 and barbed suture was used.During the procedure, the surgeon performed a laparoscopic resection of the bowel and a mechanical laparoscopic anastomosis using a manual endogia ultra with 45mm violet tri-staple cartridge.The bowel hole was closed with barbed suture.It was reported that the patient has right colon cancer and barbed suture was used on anastomotic breach between small and large intestine.It was reported that the barbed suture was used to close the common channel, barbed suture was not used for oversewing, and mechanical anastomosis was performed.The suture seemed okay, but during the night the patient needed to go back to the or urgently due to peritonitis.The patient was re-operated on (b)(6) 2019.During the procedure when abdomen was checked, they found the hole of the anastomosis opened and the barbed suture was completely out of the tissue, letting bowel content to exit into the abdomen.It was reported that the barbed suture didn't keep the tissue blocked, and the barbed suture was removed during the reoperation.The abdomen was cleaned with repeated washings, and the hole of the anastomosis was sutured with a common suture, non-continuous technique.The patient was administered antibiotic therapy and the patient was already in the hospital.The surgeon opined that it was doubted that the reload of 45mm used to anastomize was short and caused an occlusion.The surgeon opined that when the feces brought the tissue to maximum tension, the suture gave way, causing feces to escape into the abdomen.The current patient status is reported to be okay.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 3-0 S/A SH
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9416314
• MDR Text Key: 184082092
• Report Number: 2210968-2019-90585
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235809
• UDI-Public: 10705031235809
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: SXPP1B420
• Device Lot Number: PDR685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR