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

Catalog Number ILSX

Device Problem Use of Device Problem (1670)

Patient Problems Failure to Anastomose (1028); Hematoma (1884); Unspecified Infection (1930); Ulcer (2274); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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 surgeon/author believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

It was reported via journal article title: linear stapled gastrojejunostomy results in fewer strictures compared to circular stapled gastrojejunostomy in laparoscopic gastric bypass surgery.Authors: larissa vines, thomas frick, stefan aczél, dagmar l¿allemand, jan borovicka, marc schiesser.Citation: langenbecks arch surg.2017; 402: 911¿916.Doi: 10.1007/s00423-017-1598-1.Currently, there are two laparoscopic stapling techniques to perform the gastrojejunostomy in gastric bypass surgery: the linear stapling and circular stapling techniques.The aim of the study was to compare the two techniques regarding postoperative morbidity and weight loss at an accredited bariatric reference center in switzerland.The authors compared two consecutive cohorts at a single institution between november 2012 and june 2014 undergoing laparoscopic gastric bypass surgery.Of which, 109 patients (66 female and 34 male patients; age 44.9 ± 12.8 years; bmi: 44.3 ± 5.8) with the 21-mm circular stapling technique (csa) and 134 patients (72 female and 38 male patients; age: 41.9 ± 11.7; bmi: 43.5 ± 5.8) with the linear stapling technique (lsa).During the surgical procedure in the lsa technique, caution was taken to insert the stapler no more than 2 cm.The enterotomy was then closed using a single layer hand-sewn continuous suture with pds 3-0 suture (ethicon).In the csa technique, after preparation of the pouch with one echelon horizontal 60-mm stapler line (ethicon), an ils circular stapler head 21-mm (ethicon) was inserted through a gastrotomy at the greater curvature close to the first stapler line.Then, a vertical stapler line (60 mm) was applied close to the angle of his in order to complete the pouch formation and to separate the gastrotomy from the pouch.After identification of the ligament of treitz and measurement of 50-cm jejunal limb, the circular stapler was inserted into the jejunal limb and connected to the stapler head to form the gastrojejunostomy.Then, the 21-mm circular stapler was fired and withdrawn without any plastic sheet.The jejuno-jejunal anastomosis was created side to side using the echelon stapler (ethicon) after measurement of 150-cm roux limb.Finally, the gastrojejunostomy was separated from the jejuno-jejunostomy using an echelon stapler (ethicon).All mesenteric defects were closed at the end of both procedures.The circular stapler insertion site was cleaned with two sterile gauzes to prevent subcutaneous infection.In the csa group, reported complications included stenosis (n-17), leakage (n-2) which needed immediate laparoscopy with reconstruction of the gastrojejunostomy, marginal ulcer (n-1), hematoma (n-1) and was managed conservatively, wound infection (n-2) in which one case could be treated without any further measures and healed spontaneously and the other wound needed to be opened and cleaned and antibiotic treatment was initiated, and others (n-3).In the lsa group, reported complications included leakage (n-1) which needed immediate laparoscopy with reconstruction of the gastrojejunostomy, hematoma (n-1) which required placement of a computed tomography-guided drainage, and others (n-2).In conclusion, the data showed that there is no advantage in using the 21-mm csa technique compared to the lsa technique.On the contrary, the stricture rate is higher with no difference concerning weight loss at 1 year.Therefore, the lsa technique might be the preferred technique to perform the gastrojejunostomy in lrygb.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8704160
• MDR Text Key: 148272364
• Report Number: 3005075853-2019-19797
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: 05/23/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention