MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Hernia (2240); Insufficient Information (4580)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch#: unknown.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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.Does the ethicon devices mentioned in this article caused/contributed to the reported events in the article? 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, or its employees that the report constitutes an admission that the product, ethicon, 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 field as appropriate.

Event Description

It was reported via journal article: title: improved clinical and financial outcomes in proximal gastric bypass surgery following the transition from a conventional circular stapling to an augmented linear stapling protocol.Authors: nina roemer, fabian hauswirth, henrik teuber, michel teuben, thomas a.Neff3, · markus k.Muller.Citation cite: obesity surgery (2022) 32:1601¿1609 https://doi.Org/10.1007/s11695-022-05993-2.This was a cohort study conducted at a single-center, university- affiliated teaching hospital and a reference center for bariatric surgery certified by the swiss study group for morbid obesity (smob).Between 2011 and 2018, 454 patients were included in this retrospective study.The circular bypass protocol (circ; n = 177) was used between 2011 and 2012.Between 2013 and 2015 the transition occurred.Thereafter, the augmented linear protocol (alin; n = 277) was primarily utilized.Circular laparoscopic gastric bypass procedures were performed as originally described by wittgrove and clark using a 25-mm circular stapler to perform the gastroenteral anastomosis.Mesenteric windows were closed at the level of the entero-enteral anastomosis with nonabsorbable single stich sutures (ethicon, ethibond 2¿0).Reported complications included internal hernia (n=36), leakage of the gastrojejunostomy (n=13), leakage of the entero-enterostomy (n=2), stenosis (n=2), anastomotic stenosis (n=19).In conclusion this study shows improved clinical and financial outcomes after a gradual transition from a circular stapling protocol to an augmented linear stapling protocol in proximal gastric bypass surgery.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16589665
• MDR Text Key: 311742626
• Report Number: 3005075853-2023-01820
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention