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

Catalog Number EL5ML

Device Problems Unintended Ejection (1234); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r9215l.Device analysis: the analysis results found that the el5ml device was received with no damage in the external components.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon firing of the device, the tip of the advancer was noted broken causing that the clip did not fully advance into the jaw.Due to the condition of the device, no functional testing could be performed to evaluate the incident reported.In order to evaluate the condition of the internal components the device was disassembled; upon disassemble 0 clips were found inside clip track.One possible cause for the condition found is actuating the device when the jaws are not clear of the trocar.Actuating the device with the jaws closed may bend the advancer.Subsequent actuations or manual opening of the device may bend the advancer tip back toward its original position and break the advancer tip.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.In addition, the device locked out as intended.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during a laparoscopic cholecystectomy, the device was locked at the time of the shot.The surgeon took it out of the cavity and shot to the floor, but 3 to 4 clips came out in one shot.Another ligamax was used to finish the procedure.The surgery was delayed by 10-minutes.The procedure was completed successfully.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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8464651
• MDR Text Key: 140921153
• Report Number: 3005075853-2019-17657
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2019

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 Expiration Date: 12/31/2022
• Device Catalogue Number: EL5ML
• Device Lot Number: R4024K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1