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

Catalog Number LTXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/26/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.Additional information was requested and the following was obtained: "spoke with patient this morning who indicated she underwent a mastectomy 7 years ago and titanium clips were implanted.She does not know the specific clip applier used but is gathering the information and happy to share.She has multiple allergies that are typically controlled by diet but reports she ¿has a slew of symptoms that are not tied to any one thing.¿ she is now treating with shan wu, md in cleveland and reports that allergy patch testing reveals she is allergic to five metals, one of which being titanium.She was recommended to take zyrtec and is now also on a higher dose antihistamine.Her surgeon is willing to remove the clips but is concerned that may not result in symptom resolution.Patient is happy to share allergy test results and information needed.She would like the material composition of the clips and understands we need to identify the product in order to provide accurate information.She will get back to me when she has the information." 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: "please clarify "experiencing unknown symptoms from the titanium clips".What symptoms are being experienced? when did the symptoms start?" 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 post op to a breast procedure, the patient is experiencing unknown symptoms from the titanium clips used in the case.No other information is available.

• Brand Name: LIGACLIP EXTRA TITANIUM CLIPS
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18015922
• MDR Text Key: 326678425
• Report Number: 3005075853-2023-07901
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LTXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other