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

Catalog Number EL5ML

Device Problem Failure to Form Staple (2579)

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

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is (b)(6) 2019.Event day was not provided.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that post-op following a lap cholecystectomy procedure, the patient had to be brought back because of a bile duct clip that was scissored.The bile duct was leaking and the clip malformation issue was identified at re-operation.The bile duct was properly clipped and secured during re-operation.

• 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: 9288506
• MDR Text Key: 184848807
• Report Number: 3005075853-2019-23290
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention