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

Model Number EL5ML

Device Problem Failure to Form Staple (2579)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts are being 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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported by the sales rep that during a laparoscopic cholecystectomy, the clip was formed in a teardrop shape.The device was used on the cystic artery.No bleeding occurred.Another device was used to complete the case.There were no adverse consequences to the patient.The patient¿s condition is stable.

Manufacturer Narrative

(b)(4).Date sent: 1/20/2022 d4: batch # v95a6v investigation summary the product was returned for evaluation.In addition, a tyvek wrapper was received along with the device.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined the el5ml device was received with no damage to the external components.In addition, three formed clips, four gap clips, and one unformed clip were received inside of a plastic bag.Upon cycling the device, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips.A a result, the instrument could no longer be fired due to the activation of the lockout mechanism.The instrument has an orange indicator that appears on the top of the handle as a reference for the user regarding the number of clips remaining in the device.As the device was returned empty for evaluation, we were unable to investigate further the issue of ¿malformed clips." the device was disassembled to verify the condition of the internal components and no anomalies were noted.The event described could not be confirmed as the device was returned empty and no product defect was identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following: "caution: when the thirteenth clip is fired, an orange bar will begin to appear in the indicator window on top of the device handle.The orange bar fills the indicator window when the final clip is fired." 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 batch number, and no non-conformances were identified.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13032457
• MDR Text Key: 286668229
• Report Number: 3005075853-2021-07931
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1