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

Catalog Number EL5ML

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Diaphoresis (2452); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/26/2024.D4: batch # unk.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: "may we contact your physician in reference to this complaint? if yes, please provide physician contact information." attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that after a cholecystectomy, the patient began to experience fever, heavy sweating, lumps in thighs, could be the clips that were left behind.

Manufacturer Narrative

(b)(4).Date sent: 4/16/2024.Additional information was requested and the following was obtained: "patient stated that they are in contact with an allergist to test for metal allergies.Allergist initially thought that the patient had an autoimmune disease and prescribed prednisone.Once it was discovered that metal clips were placed in the patient it was decided to do an allergy patch test.The patch test cannot be performed until the patient tapers off / or gets to as low as possible dose on the prednisone.".

Manufacturer Narrative

(b)(4).Date sent: 4/24/2024.Additional information was requested and the following was obtained: "operating physician stated that he does not think the clips would be causing these issues.He spoke to the patient about his weight and how being on a high dose steroid for so long could be causing issues.".

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18588414
• MDR Text Key: 333852873
• Report Number: 3005075853-2024-00774
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 03/21/2024; 04/17/2024
• Supplement Dates FDA Received: 04/16/2024; 04/24/2024
• 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): Other