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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Pain (1994)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional information was requested, and the following was obtained: did device not feed clips? did device feed clips sideways? did device not fire clips (jammed)? did device fire malformed clips? did device fire scissored clips? did device drop or eject clips? did the clips not hold in tissue or vessel? was there any issue with bleeding? if yes, what was the amount of the blood loss (mls)? was a transfusion required? how it is the bleeding was controlled? was the procedure altered as a result of the event? if other, please clarify were there any patient consequences? if yes, please describe.Answer = iq (b)(6) 2022 cole lap elective without incidents.Discharge without incident, reconsult emergency room (b)(6) 2022 for poorly controlled pain, somewhat unstable with hypota.Ct scan with fluid so referred directly to santpau.(b)(6) 2022 percutaneous pigtail drainage placed.(b)(6) 2022 second pigtail drainage due to accidental removal of the first one.Cholangiorm (b)(6) 2022: cystic leak - ercp covered metal biliary prosthesis hospital discharge (b)(6) 2022.Currently eco control without collections, pending ercp to remove prosthesis.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: how was each clip applied? does surgeon load the clip off of the vessel before applying to the vessel and then fire? which firing of the device did this event occur on? what vessel or structure was the device fired on at the time of the event? was the clip fully advanced into the jaws prior to firing? was there any torquing or twisting of the device present at the time of firing? was any unexpected resistance felt while firing the trigger? were any unexpected noises heard? if so, when? did anything unexpected happen prior to this incident? was the device fired after this incident in or out of the patient?.

Event Description

It was reported that during a cholecystectomy, the customer suspects a bad clips application.There were patient consequences.

• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14079113
• MDR Text Key: 290174241
• Report Number: 3005075853-2022-02249
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2022

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 Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/11/2022
• 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): Hospitalization; Required Intervention