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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE Back to Search Results
Model Number EL5ML
Device Problems Failure to Fire (2610); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date sent: 5/16/2023.D4: batch # a9ce5w.Additional information was requested and the following was obtained: "please confirm the month of the event: march please clarify how ¿product went "down": clip applied to tissue and handle was squeezed.No clips deployed.Did device not feed clips? correct.Did device feed clips sideways? n/a.Did device not fire clips (jammed)? yes.Did device fire malformed clips? no.Did device fire scissored clips?no.Did device drop or eject clips? no.If other, please specify." 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 returned with one jaw disengaged from the cam; this condition would not allow the jaws to collapse in order to form the clips.In an attempt to replicate the reported incident, the device was tested for functionality.In order to evaluate the performance of the device, the jaw was readjusted and in the next actuations, 5 conforming clips were fed and formed; finally the device locked out as intended.Possible causes for the condition of the jaw disengaged from the cam may be inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor or damage to the jaws while entering the trocar.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 the unknown procedure, the device went "down".No other information was given.The procedure was successfully completed with no patient harm.
 
Manufacturer Narrative
(b)(4).Date sent: 9/1/2023.Correction h6.Investigation conclusions: d11 h6.Investigation conclusions.
 
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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 Key16942680
MDR Text Key315391445
Report Number3005075853-2023-03344
Device Sequence Number1
Product Code FZP
UDI-Device Identifier10705036001843
UDI-Public10705036001843
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/01/2023
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 NumberEL5ML
Device Catalogue NumberEL5ML
Device Lot NumberA9CE5W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/24/2023
Initial Date FDA Received05/16/2023
Supplement Dates Manufacturer Received08/15/2023
Supplement Dates FDA Received09/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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