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

Model Number EL5ML

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u95y8n.(b)(4).Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the el5ml device was returned with no damage to the external components.In an attempt to replicate the reported incident, the trigger was noted to be hard.The device was disassembled in order to evaluate the condition of the internal components and evidence of corrosion was found on the welded push rod, the jaw/cam sub-assembly and welded jaw retainer did not allow the trigger to be moved.Seven clips were also found inside the clip track.The event reported was confirmed and it is related to improper use of the device.Regarding the found corrosion, the most likely root cause is exposure to a solution containing chlorine.In order to avoid this kind of issue, please do not reuse, reprocess or re-sterilize the device.Reuse, reprocessing or re sterilization may compromise the structural integrity of the device and/or lead to device failure that in turn, may result in patient injury, illness, or death.Please reference the instructions for use for more information.As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.

Event Description

It was reported that during a cholecystectomy procedure, the device was defective.No patient consequence mentioned.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12214258
• MDR Text Key: 263127304
• Report Number: 3005075853-2021-04092
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: U95Y8N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1