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

Model Number EL5ML

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

Patient Problem Failure to Anastomose (1028)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

Pc-(b)(4).Date sent: 7/5/2023 d4: batch # unk.Additional information was requested and the following was obtained: "-what is surgeon¿s experience with this device? many years of using this device.-does the surgeon load the clips off of the vessel into the device jaws before applying the device jaws to the vessel and firing? no -were the clips visualized endoscopically during the initial surgical procedure? yes -stated that, ¿did not notice anything abnormal with the clip applier during the procedure.¿ were there any abnormalities with the actual clips during the initial procedure? no -did any other issues occur during the initial procedure? no -what was the total number of clips used? 4 -which firing did the incident occur on? no -how many days postoperative did the leak occur?2 -how was the leak addressed? reoperation? -if reoperation, was it open or laparoscopic? ercp -what was observed at the site of the leak upon reoperation? malformed clips? scissored clips? no reoperation -what is current patient status? stable -will the device be sent in for analysis? if already sent, please provide the tracking information.No" an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Event Description

It was reported that post-op to a cholecystectomy procedure, the patient returned experiencing issues.Er ct was completed and confirmed leak.He did not notice anything abnormal with the clip applier during the procedure.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17262209
• MDR Text Key: 318557082
• Report Number: 3005075853-2023-04634
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/05/2023

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 Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2023
• Initial Date FDA Received: 07/05/2023
• 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