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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 Problem Firing Problem (4011)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic sigmoidectomy, the firing force was higher than expected and 2 clips deployed at the same time.The device was used on the blood vessels.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 # x94n8t.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.In addition, a plastic bag with 2 malformed clips, 1 conforming, 4 unformed clips were returned along with the instrument.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.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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.The event described could not be confirmed as the device was returned empty.
 
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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
*  00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
*   00969
Manufacturer Contact
orla o'mahony
475 calle c
guaynabo 
*  
329348013
MDR Report Key15234802
MDR Text Key305367863
Report Number3005075853-2022-05328
Device Sequence Number1
Product Code FZP
UDI-Device Identifier10705036001843
UDI-Public10705036001843
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 08/16/2022
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 NumberEL5ML
Device Catalogue NumberEL5ML
Device Lot NumberX94N8T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2022
Initial Date Manufacturer Received 08/09/2022
Initial Date FDA Received08/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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