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

Catalog Number ERXXX

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 06/27/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent: 9/30/2021.Batch # unk.Publication date of journal article is 6/27/2020.This report is related to a journal article; therefore, no product will be returned for analysis.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during review of a journal article: title: futility of abdominal drain in elective laparoscopic splenectomy.Authors: l.Degrate, c.Zanframundo, d.P.Bernasconi, g.Real, m.Garancini, f.Uggeri, f.Romano, m.Braga.Citation: langenbeck's archives of surgery (2020); 405:665¿672.Https://doi.Org/10.1007/s00423-020-01915-x.The aim of this retrospective study was to assess whether the abdominal drain can impact on short-term outcome after elective laparoscopic splenectomy.A total of 161 patients [76 male and 85 female; median age of 21 years (range, 3-84 years)] who underwent elective laparoscopic splenectomy between january 2001 and june 2019, were included in the study.Transection of hilar splenic vessels was performed with competitor device or clips (ligaclip® ethicon/johnson&johnson, usa or competitor device) or vascular staplers from competitor.Clips or vascular staplers were used only in case of splenic vessels¿ calibre larger than 7 mm in 19 patients (table 1).Reported complications include operative bleeding (n=?) requiring a conversion to open surgery, anaemia (n=?) requiring transfusion, abdominal collection (n=?), hemoperitoneum (n=?) requiring reoperation, portal vein thrombosis (n=?), bleeding through the drain (n=?) requiring reoperation, other medical complications (n=?), and death (n=?).In conclusion, the results of our study do not support the routine use of drain in elective ls.In fact, the placement of a drain did not allow reducing postoperative morbidity, whereas it was associated with prolonged los.

Manufacturer Narrative

(b)(4).Date sent: 10/13/2021.H2: additional information received: additional information was requested from surgeon/author and the following was obtained: "dear sirs, i don't believe that the ethicon ligaclip devices caused or contributed to the patient complications mentioned in the article.Best regards." upon review of the information provided, it was concluded that this event no longer meets the fda defined criteria for a reportable event and is being considered not reportable.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12558689
• MDR Text Key: 274201042
• Report Number: 3005075853-2021-05852
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ERXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention