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

Model Number LT200

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 05/16/2022

Event Type  Injury  

Event Description

It was reported that during an unknown procedure the patient had medium ligaclips applied to her neck 2 years ago when she had surgery to remove small bone pieces.Shortly thereafter, she developed inflammation, pain, difficulty breathing and cysts.Patient believes she is having a reaction to the clips, so she is searching for a surgeon to remove them.She says that "she is dying" and is desperate to have them removed.Two weeks ago surgeon went in to remove the clips and found infection.She was placed on antibiotics, but no specimen was sent to pathology to confirm infection.She has been traveling back to (b)(6) from (b)(6) to see her original surgeon and now seeks to locate a surgeon in (b)(6) or leave the country to have the clips removed.Erd nurse advised patient to find surgeon and if not able, then to go to emergency room for difficulty breathing and pain.

Manufacturer Narrative

(b)(4).Batch #: unk.Date of event: unknown; captured as awareness date.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.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: can you please provide the contact information for both surgeons? do we have permission to contact them? has the patient undergone metal allergy testing? if so, can the results be shared? 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: 6/2/2022.H10 additional information was requested, and the following was obtained.Correction should have said: 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:.

• 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: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14574691
• MDR Text Key: 293251962
• Report Number: 3005075853-2022-03548
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: 10705036012801
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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 Model Number: LT200
• Device Catalogue Number: LT200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 06/02/2022
• 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