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

Catalog Number EL5ML

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

Patient Problems Failure to Anastomose (1028); Sepsis (2067)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that post op of a laparoscopic cholecystectomy procedure, the patient developed a bile leak causing sepsis.An x-ray reviled that the clip had slid off the duct.No additional information.

Manufacturer Narrative

(b)(4).Date sent: 4/4/2024.B3: unknown, assumed first day of month that complaint was reported.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: "what is the surgeons experience with this device? were the clips visualized endoscopically during the initial surgical procedure? were there any complications during the initial surgical procedure? how many clips were used to close the duct? were there any surgical complications when clipping the duct due to patient factors? please describe the shape of the clip that slid off.Was it ribbon shaped or x-shaped? was it pear/tear drop shape or clip gap? what is current patient status?" 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.

Manufacturer Narrative

(b)(4).Date sent: 5/15/2024.Additional information was requested and the following was obtained: "what is the surgeons experience with this device? the surgeon is familiar with the device and has been using it without issue until this report on (b)(6) 2024.Were the clips visualized endoscopically during the initial surgical procedure? unconfirmed.Were there any complications during the initial surgical procedure? unconfirmed.How many clips were used to close the duct? unconfirmed.Were there any surgical complications when clipping the duct due to patient factors? unconfirmed.Please describe the shape of the clip that slid off.Was it ribbon shaped or x-shaped? was it pear/tear drop shape or clip gap? unconfirmed.What is current patient status? no further information on patient status outside of original icu admittance from developing sepsis from the bile duct leak post-operatively.".

• 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: 19047223
• MDR Text Key: 339430047
• Report Number: 3005075853-2024-02628
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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?: Yes
• 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: Not provided
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/15/2024
• 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): Required Intervention