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

Model Number EL5ML

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: t94g01.Investigation summary: the analysis results found that the el5ml device was received inserted into a b5lt trocar with one jaw disengaged from the cam.This condition would not allow the jaws to collapse in order to pull out the el5ml device from the trocar.In order to evaluate the performance of the device, the jaw was readjusted and in the next activation, 10 conforming clips were fed and formed.Finally, the device locked out as intended.Possible causes for the condition of the jaw disengaging 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Attempts were being made to obtain the following information: what is meant by the device misfired? did the device fire clips and then stop firing? did the clips drop or eject from the jaws of the device? did the device not fire at all? were the clips malformed, scissored? to date, no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during a laparoscopic cholecystectomy, the device misfired.A similar device was used to complete the case.There were no patient consequences.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9847171
• MDR Text Key: 199084047
• Report Number: 3005075853-2020-01679
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

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
• Device Lot Number: T94G01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1