MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

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

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 11/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed 1st day of month that complaint was reported.Batch # unknown.Possible lots p4rx7c, p4rz58 & p4t20y.The device history records were reviewed and the manufacturing criteria were met prior to the release of these lots.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.What was the surgical procedure the device was used in? what was the anatomical position where the device was used? is it the surgeon¿s normal routine to load and inspect the clip off vessel prior to deploying? was there a re-operation prior to the death? does autopsy report identify the site of the bleeding and the cause of bleeding? is the autopsy report available? if yes, please send to (b)(6).

Event Description

It was reported that after a laparoscopic unknown surgery in which el5ml and suture were used, intraperitoneal bleeding occurred, and the patient died on (b)(6) 2017.No problem such as unformed clip was observed during the surgery on (b)(6) 2017, and no additional treatment was required at that time.After the procedure, bleeding occurred, and the patient¿s condition became worse suddenly.The amount of bleeding was unknown.No blood transfusion was performed.It was unknown where the bleeding occurred.After the procedure, the patient was discharged from the hospital.Soon after leaving the hospital, the patient was died.Bleeding in the body cavity was confirmed by the autopsy.

Manufacturer Narrative

(b)(4).Corrected data: based on the additional information received this file does not meet the defined criteria of an adverse event.Was there any alleged deficiency of the vicryl suture that contributed to the post-operative complications and patient death? it was not reported that there was a direct problem with ethicon products.Does this also include the el5ml? meaning that there was no report that there was a direct problem with the ethicon products to include the el5ml? yes.It was not reported that there was a direct problem with the ethicon products to include the el5ml.No further information about the amount of bleeding, the point of bleeding and the reason of death will be provided.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: "what was the surgical procedure the device was used in? unknown laparoscopically.No further information is available from the hospital.What was the anatomical position where the device was used? no further information is available from the hospital.Is it the surgeon¿s normal routine to load and inspect the clip off vessel prior to deploying? no further information is available from the hospital.Was there a re-operation prior to the death? no information from the hospital.After the procedure, the patient was discharged from the hospital.Would the surgeon be willing to speak with ethicon medical and engineering personnel? no.Does autopsy report identify the site of the bleeding and the cause of bleeding? no further information is available from the hospital.Is the autopsy report available? no.".

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8273965
• MDR Text Key: 134000195
• Report Number: 3005075853-2019-16126
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death