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

Catalog Number EL5ML

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Failure to Anastomose (1028); Pain (1994); No Code Available (3191)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was received: what was the procedure? lap cholecystectomy.Surgeon: dr (b)(6).Primary procedure date: didn¿t provide.Event reported by surgeon: clips malformed once fired.Clip came out in a j shape ¿like a hockey stick¿.Were there any other devices used within the same procedure e.G.Stapler? not provided.How many post-op did the ae occur: the next day once the patient went home.Patient called dr reporting pain.Reason for patient to be readmitted: please specify if it was due to bleeding? or bile leak? and where the location was.Bile leak.What had to be done to manage? a second operation was completed was the patient sent to icu? unknown.Additional follow-up questions were asked, and the following was obtained: did they receive j-shaped clips and a multiple feed issue? dr (b)(6), from our previous conversation i have confirmed that you experienced j-shaped clips (like a hockey stick as you described).Did you also experience a multiple feed issue as well (several clips firing at the same time?) - no.Did the surgeon ensure that the line of demarcation was completely through the trocar prior to loading the clips that were used? - yes.After experiencing the initial product issue, did you observe if the clip was correctly shaped and loaded before firing on the vessel? did the clip mis-shape only after firing? yes - noticed after firing.Once the clip malformation issue was identified what was done intra-operatively to address this issue? - removed the clip from the abdominal cavity and use a different device.

Event Description

It was reported that during a laparoscopic cholecystectomy, clips firing over self.The procedure was delayed by 3-minutes.New product opened to successfully complete the case.There were no patient consequences.

Manufacturer Narrative

(b)(4).Batch # r94y3j.Device analysis: the analysis results found that the el5ml device was returned with no damage in the external components.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 7 conforming clips.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device lot r94y3j number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch r94y3j number, and no non-conformances were identified.

• 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: 8595240
• MDR Text Key: 144564443
• Report Number: 3005075853-2019-18913
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: R94Y3J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 06/06/2019
• Patient Sequence Number: 1