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 04/01/2022

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.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: what is the alleged deficiency with the device? the surgeon believes that the clips formed incorrectly which has lead to the leak with this patient were there any clip formation issues identified throughout care of the patient? none- this was post operation.Was there any clip formation issue during the surgical procedure? none were identified.Was there any difficulty with device intraoperatively? no.Could clip presence or formation be confirmed during port-op scan? unknown at present ¿ i will have to confirm this with surgeon.Was the clip loaded in the jaw of the device while off the vessel prior to closing jaws on vessel? yes.How many clips were placed on the patient side of cystic duct? unknown , i will confirm with surgeon.

Event Description

It was reported that after an unknown procedure, the surgeon experienced a cystic duct leak with a patient.This was a post op leak.Everything looked fine during the operation and the patient also is well again and has suffered no long term effects.

• 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: 14336849
• MDR Text Key: 291211801
• Report Number: 3005075853-2022-02963
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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
• Date Manufacturer Received: 04/14/2022
• 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): Required Intervention; Hospitalization