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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); Failure to Fire (2610); Noise, Audible (3273)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, an unexpected sound was heard and the deployed clip was formed in a teardrop shape when the trigger was grasped.Jamming occurred.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, an unexpected sound was heard and the deployed clip was formed in a teardrop shape when the trigger was grasped.Jamming occurred.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4)date sent: 3/21/2022 investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was received with no damage to the external components.Upon cycling, the instrument was noted to be empty and locked out and no noise was heard.The instrument is designed to lock out after all the clips have been fired; therefore, a potential cause of the customer reported experience is the firing of all of the clips and the instrument "will not fire" (activation of the lock out mechanism).In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.Please note that the condition of the orange indicator is unrelated with the report incident.No conclusion could be reached as to what may have caused the condition of the indicator.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: insert the clip applier through an appropriately-sized trocar.The empty jaws will passively collapse as they are inserted through a 5 mm trocar and reopen when completely through the trocar.Prior to positioning the jaws around the tubular structure or vessel, load a clip into the jaws by partially squeezing the trigger in a smooth continuous motion for approximately one-third of the total firing stroke.Prior to loading a clip in the jaws and firing the instrument: ensure that the jaws are fully open by verifying that the line of demarcation between the jaws and the instrument shaft is past the distal end of the trocar cannula.Prior to positioning the jaws around the tubular structure or vessel, load a clip into the jaws by partially squeezing the trigger in a smooth continuous motion for approximately one-third of the total firing stroke.Position the jaws with the preloaded clip completely around the tubular structure or vessel to be ligated.The structure to be ligated should be positioned against the apex of the clip.The event described could not be confirmed as the device performed without any difficulties noted.

• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13477138
• MDR Text Key: 286130355
• Report Number: 3005075853-2022-00715
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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: V95F82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1