MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LAPRA-TY* APPLIER - 33CM; APPLIER, SURGICAL, CLIP

Catalog Number	KA200
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abdominal Pain (1685); Abscess (1690); Fever (1858); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of report: publication year for the journal article is 2017.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during review of a journal article, title: proximal leakage after laparoscopic sleeve gastrectomy: an analysis of preoperative and operative predictors on 1738 consecutive procedures.Author/s: giovanni cesana, stefano cioffi, riccardo giorgi, roberta villa1, matteo uccelli, francesca ciccarese, giorgio castello, bruno scotto and stefano olmi.Citation: obes surg (2018) 28:627¿635; doi 10.1007/s11695-017-2907-z; published online: 24 august 2017.The purpose of this retrospective study was to search for predictive factors for proximal leakage after laparoscopic sleeve gastrectomy (lsg) in a large cohort from a single referral center.From january 2008 to october 2016, one thousand seven hundred and thirty-eight patients (median age 41.0 (33.0 to 49.0) years, male n=428, female n=1310) who underwent laparoscopic sleeve gastrectomy were analyzed.Lsg was performed using four trocars.The great curvature was dissected and isolated from the gastrocolic ligament and the splenocolic ligament through an ultrasonic device (harmonic ace, ethicon endo-surgery inc., cincinnati, ohio) or a radiofrequency sealer device (ligasure maryland jaw, medtronic, dublin, ireland; or conmed altrus, conmed electrosurgery, centennial, co, usa) or an integrated device of both advanced bipolar energy and ultrasonic energy (thunderbeat, olympus medical system corp., tokyo, japan).The linear stapler used were covidien endo gia 60 reloads with or without tri-staple technology (medtronic, dublin, ireland) and ethicon echelon flex 60 endopath stapler (ethicon endo-surgery inc., cincinnati, oh).The choice of a particular cartridge depended on the tissue thickness according to the intra-operative perception and experience of the surgeon.In most of the lsgs, the highest part of the suture was reinforced with an overriding suture: pds 3/0 (mic55e, pds ii, ethicon endo-clip suture, cincinnati, oh, usa) or polysorb 2/0 (endostitch suturing device, covidien, dublin, ireland), or with buttress material: bovine pericardium (peri-strip dry, synovis life technologies, inc., st.Paul, mn, usa) or polyglycolic acid (endo gi reinforced reloaded with tri-staple technology, medtronic, dublin, ireland).Complications included leakage at the bottom of gastric suture (n=3) which was easily managed by a laparoscopic intervention with suture of the gastric dehiscence; leakage at the proximal part of the gastric suture (n=45), abdominal pain (n=45), fever (n=45) and abdominal abscess (n=42).In conclusion, in this large consecutive cohort study of lsg, proximal staple line reinforcement (buttress material or suture) reduced the risk of a leak.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent: 2/21/2020.H1: mdr decision: not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Response from the author: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.No.

• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9624975
• Report Number: 3005075853-2020-00524
• Device Sequence Number: 13541658
• Product Code: GDO
• UDI-Device Identifier: 10705036012641
• UDI-Public: 10705036012641
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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: KA200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention