MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR/GRN RLD; STAPLE, IMPLANTABLE

Catalog Number	ATG45
Health Effect - Clinical Codes	Abscess (1690); Obstruction/Occlusion (2422); Blood Loss (2597); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported through journal article title: analysis of endoloops and endostaples for closing the appendiceal stump during laparoscopic appendectomy authors: mislav rakic, miro jukic, zenon pogorelic, ivana mrklic, robert klicek, nikica druzijanic, zdravko perko and leonardo patrlj citation: surg today (2014) 44:1716¿1722; doi 10.1007/s00595-013-0818-8; published online: 12 december 2013.The aim of this study was to assess the efficiency of each technique by focusing on the intraoperative and postoperative complications versus cost.Between june 2011 and june 2013, a total of 333 patients (188 males and 155 females with age range from 5 to 80 years old) who underwent laparoscopic appendectomy (la) were included.The data were grouped according to the stump closure technique; a stapler group (endopath-endocutter atg45, ethicon endo-surgery, cincinnati, oh, usa) (104 patients; 31.2 %) and an endoloop group (vicryl-endoloop 0; ethicon endo-surgery, (b)(6) usa) (229 patients; 68.8 %).The mesoappendix was dissected, depending on the surgeons¿ preferences, with either a harmonic scalpel (ultracisiontm, ethicon endo-surgery, (b)(6) usa), a bipolar tissue sealing system (ligasuretm, valleylab, boulder, co, usa) or using thermal fusion technology (misealtm, microline).Among the 333 patients who underwent la, there was one case of bleeding from the mesoappendix).Postoperative complications were seven (2.1 %) wound infections (four in the stapler group, three in the loop group), seven (2.1 %) intraabdominal abscesses (three in the stapler group, four in the loop group), five (1.5 %) small bowel obstructions (two in the stapler group, three in the loop group), five (1.5 %) small bowel obstructions (two in the stapler group, three in the loop group), and one (0.3 %) appendix stump insufficiency in the loop group.The authors performed a reoperation in only three patients.In conclusion, there is no clinical evidence supporting the routine use of endoscopic staplers.The appendiceal stump can be secured safely with the use of endoloops in the majority of patients.Surgeons have to be more selective when choosing how to perform closure, and an endostapler should be used only in cases where it is clinically indicated.

• Brand Name: 45MM ARTICNG LNR CUTR/GRN RLD
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8208219
• Report Number: 3005075853-2019-15431
• Device Sequence Number: 265073
• Product Code: GDW
• UDI-Device Identifier: 10705036001065
• UDI-Public: 10705036001065
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ATG45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention