MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Model Number LT300

Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure to Anastomose (1028); Inflammation (1932); Pain (1994); Discomfort (2330); Abdominal Distention (2601)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: were the clips visualized endoscopically during the initial surgical procedure? how many days postoperative did the leak occur? how was the leak identified? where was the leak anatomically located? how was the leak addressed? prior to loading, can you please confirm each of clip cartridges were placed in the lc800 metal base? please confirm the brand and or product code of the clip applier used with the lt300 clips? were malformed or scissored clips observed? if yes, please describe shape.Prior to use, did the or staff confirm alignment of the jaws of the clip appliers as requested in the ifu? two other events were also reported, (b)(4) and (b)(4), were these all 3 separate patients and events? did the surgeon experience any difficulties using the clip applier? if so, please describe.What is current patient status? 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.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 procedure, the patient is in the icu with a bilioma because it leaked through the clip.

Manufacturer Narrative

(b)(4).Date sent: 12/15/2022.Additional information was requested and the following was obtained: "¿ were the clips viewed endoscopically during the initial surgical procedure? - yea.¿ how many days postoperative did the leak occur? - leakage occurred after 2 days postoperatively.¿ how was the leak identified? ¿ distended abdomen, pain and discomfort.¿ where was the leak anatomically located? leakage in the cystic duct.¿ how was the leak addressed? endoscopic retrograde cholangiopancreatography was performed and a biliary stent was placed endoscopically.¿ prior to loading, can you please confirm each of clip cartridges were placed in the lc800 metal base? here in brazil we do not use this base.The cartridge is stuck on the table and the clip is removed from the cartridge using the specific clipper.¿ please confirm the brand and or product code of the clip applier used with the lt300 clips? code el314.¿ were malformed or scissored clips observed? if yes, please describe shape.No, no malformation.¿ prior to use, did the or staff confirm alignment of the jaws of the clip appliers as requested in the ifu? yup.Clippers were visually in perfect condition ¿ two other events were also reported, (b)(4), were these all 3 separate patients and events? yup.They are different patients and events occurred with different doctors as well.¿ did the surgeon experience any difficulties using the clip applier? if so, please describe.Doctor has a lot of experience, user of the jnj clip for many years without problem and after a while he started to notice the problem and changed it to the horizon brand clip.¿ what is current patient status? patient was treated and discharged without any problems" h6.Medical device problem code: a24, a27.

• 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: 15679198
• MDR Text Key: 302472073
• Report Number: 3005075853-2022-07272
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: 10705036012825
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K830503
• 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,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT300
• Device Catalogue Number: LT300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• 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