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

Model Number EL5ML

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Pain (1994); Diaphoresis (2452); Abdominal Distention (2601)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

Pc-(b)(4).Date sent: (b)(6) 2022.Batch # unk.Unknown; captured as awareness date.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.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: do you have medical records that confirm the specific product code of the clip applier device or clip that was used in your laparoscopic cholecystectomy procedure 8 years ago? do you wish to provide those medical records that document the clip applier or clip that was used in your procedure? has any allergy testing been completed by an allergy specialist to confirm that you have a titanium allergy? do you wish to provide your allergy testing results? do you wish to provide the name and contact information for your personal physician, and do you give permission to our medical safety team to contact your physician, peer to peer, regarding this reported issue and your allergy testing? has your physician/surgeon made any recommendations regarding clips being removed?.

Event Description

It was reported that the patient had an operation 8 years ago - laparoscopic cholecystectomy and titanium clips were placed.Since then, patient states that she has developed an allergy to titanium.Patient is experiencing chills and sweats, loss of hair, bloatedness, pureeing her food for 8 years, no issue have been found with her digestion or her bowels.Patient has also experienced palpitations, itchy, burning, tastes like she's eating steel/metal, pain in the area where the clips are located, side is swollen, can feel the infection in her body, and is getting headaches.Patient had a near death experience in the or and is routinely doubled over in pain.Patient stated that its killing her.Patient indicated its affecting her arm, her leg and her entire right side.Patient was not aware of her allergy to titanium.Patient stated she needs the clips removed.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: "spoke with patient today who indicated she¿s attempted to get a melisa allergy test but hasn¿t been able to find a testing facility in canada that conducts the test.She confirmed the clip applier used in her case was model pl569t made by aesculap and she thought she was speaking to someone from that company.I researched contact information for her and provided a weblink to the aesculap site for proper contact information and follow up.Patient confirmed that no ethicon device was utilized or causing her issues." upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13842572
• MDR Text Key: 287579587
• Report Number: 3005075853-2022-01696
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2023
• 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