MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); No Code Available (3191)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: publication year for the journal article is 3/25/2020.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 this 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 Description

It was reported that during review of journal article, title: a novel technique for pancreatic stump closure: clip ligation of the duct and associated suturing of pancreas authors: michail papoulas, elissaios kontis, olympia hadjicosta, nathaneal pinsker, nigel heaton, krishna v.Menon.Citation: cureus 12(3): e7414; doi 10.7759/cureus.7414.Web link to article: doi: 10.7759/cureus.7414 ; published 03/25/2020.This retrospective study aimed to present a novel technique for pancreatic stump closure using clip ligation of the duct and associated suturing of pancreas (clasp).They retrospectively reviewed a prospective database of five patients (n=3 female, n=1 male; mean age: 59.8 years; age range: 49-71 years) who underwent distal pancreatectomy (dp) and splenectomy (dps) using the clasp technique.Four patients underwent laparoscopic dps and one patient underwent open central pancreatectomy.The main pancreatic duct (mpd) was secured by application of two or three ligaclips (ligaclip 10-m/l, ethicon) on the proximal mpd and then divided.The final step of the clasp technique consists of the oversewing the pancreatic stump using a single layer, continuous 4.0 prolene suture (ethicon) approaching the lips of the pancreatic remnant.

• Type of Device: CLIP, IMPLANTABLE
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10762422
• MDR Text Key: 216682168
• Report Number: 3005075853-2020-05636
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention