MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA LARGE APPLIER; CLIP, IMPLANTABLE

Catalog Number	MCL20
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to an unknown procedure, the patient has pain and inflammation in the neck and on the right side 24/7 has to take pain medication for pain.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/27/2023.D4: batch # unk.Additional information was requested and the following was obtained: have you been prescribed medication by a doctor (not over the counter medication)? yes.If yes, what is the doctor prescribed medication? lyrica, indomethacin, meloxicam, percoset / oxycodone, prednisone.Have you had any diagnostic testing done to address the symptoms you experienced? if yes, what diagnostic testing were completed? mri soft tissue neck, cta/ctv head/neck, emg, ultrasound neck.What are the next steps when it comes to the patients care? tried stellate ganglion never block (did not work).Further treatment in process of being determined." an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/4/2023.The following additional information was obtained: "patient would not like us to contact operating physician.State that they have a nickel allergy but have been told there is no nickel in our clips.Stated that dr.Did not tell him that clips were going to be placed and were discovered during the mri.Reason for procedure: intracranial hypertension.Jugulars were both 100% stenosed.Stated that during the procedure, the surgeon damaged the cranial nerve and brachial plexus.Veins are still 100% stenosed.Neck feels inflamed and spongey.States that procedure was in (b)(6) 2021 and pain started immediately after, but in (b)(6) 2022, patient fell on ice and said that made it even worse.New drs.Will not remove the clips.Wants help from j&j to find a dr./tell his current dr to take them out.".

• Common Device Name: 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: 17827143
• Report Number: 3005075853-2023-06914
• Device Sequence Number: 16764335
• Product Code: GDO
• UDI-Device Identifier: 10705036002468
• UDI-Public: 10705036002468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K820837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: MCL20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown