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

Catalog Number EL5ML

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579); Mechanical Jam (2983)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/9/2024.D4: batch # a9dy8z.Additional information was requested and the following was obtained: "the clip could not be fed into the jaw properly,=>the clip could not be clipped properly." 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: "did clips not feed or advance into the jaws? did device not deploy clip from jaws upon firing? did the clips feed sideways into the jaws? did the clip feed slower than expected into the jaws? did an unformed clip drop, eject, shoots or spit from the jaws of the device? did device fire scissored clips? this may also include ribbon shaped or x-shaped.Did device fire malformed clips?pear/tear drop shape or clip gap?" investigation summary: the product was returned to ethicon 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.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, as a result, the instrument could no longer be fire due to the activation of the lockout mechanism.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.The instrument has an orange indicator that appears on the top of the handle as a reference for the user as to the number of clips remaining.The event described could not be confirmed as the device was returned empty.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: when the 13th 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.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

Event Description

It was reported that during a laparoscopic sigmoidectomy, the clip could not be fed into the jaw properly, and the device could not be used.The device was used on the colon.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: 4/24/2024.Additional information was requested and the following was obtained: "did clips not feed or advance into the jaws? no.Did device not deploy clip from jaws upon firing? no.Did the clips feed sideways into the jaws? yes.Did the clip feed slower than expected into the jaws? currently, unknown.-did an unformed clip drop, eject, shoots or spit from the jaws of the device? no.Did device fire scissored clips? the clip did not clip the tissue properly.This may also include ribbon shaped or x-shaped.Did device fire malformed clips? pear/tear drop shape or clip gap? i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted".

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19074198
• MDR Text Key: 340578275
• Report Number: 3005075853-2024-02757
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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 Catalogue Number: EL5ML
• Device Lot Number: A9DY8Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1