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

Catalog Number EL5ML

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 01/18/2019

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.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.Was there an alleged deficiency with the el5ml device? what were the contributing factors that led to the laparotomy? why was the bleeding not able to be controlled laparoscopically? is it the surgeon¿s normal routine to load and inspect the clip off vessel prior to deploying? were there any clip formation issues noted in the procedure? if yes, please describe their shape (malformed, scissored, pear-shaped).What was the approximate size of the cystic artery? were the clips placed on the cystic artery and then fell off? how many clips were clips were placed? what is the surgeon¿s experience with the el5ml device? what is the current status of the patient?.

Event Description

It was reported that during a cholecystectomy, defective ligature of the cystic artery leading to haemorrhage requiring to change from the coelioscopy procedure to a laparotomy in emergency.All the clips, even on the cystic canal, have dropped.Suspicion of choledochal stenosis being evaluated.Actual state of the patient: uncertain.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8475134
• MDR Text Key: 140733508
• Report Number: 3005075853-2019-17745
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 89