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 Problem Failure to Anastomose (1028)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed 1st day of month that complaint was reported.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.The following information was requested, but unavailable: was the cystic duct identified at that time (during the initial procedure)? was a cholangiogram done? is it the surgeon¿s normal routine to load the clip off vessel and inspect the jaw tips to ensure the clip is fully advanced prior to deployment? was the procedure urgent/emergency or was the surgery elective? were there any clip formation issues intra-op? were there any clip formation issues identified throughout the care of the patient? how many clips were placed on the patient side? where was the leak? how was the leak addressed? were there any scans done? if yes, please send the results to (b)(6).What is the current patient status?.

Event Description

It was reported that after a laparoscopic cholecystectomy a leak was found.It is unknown how the leak was addressed.The surgeon thinks that is was caused by one of the clips scissoring.There is no additional information.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: was the cystic duct identified at that time (during the initial procedure)? yes was a cholangiogram done? yes.Is it the surgeon¿s normal routine to load the clip off vessel and inspect the jaw tips to ensure the clip is fully advanced prior to deployment? was the procedure urgent/emergency or was the surgery elective? yes were there any clip formation issues intra-op? didn¿t notice.Were there any clip formation issues identified throughout the care of the patient? didn¿t notice.How many clips were placed on the patient side? 2 clips on the patient side.Where was the leak? not intraoperatively how was the leak addressed? post op drain were there any scans done? hida scan showed leak but not specifically where.What is the current patient status? fine.

• 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: 8990987
• MDR Text Key: 161681009
• Report Number: 3005075853-2019-21897
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/03/2019
• Patient Sequence Number: 1