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

Model Number EL5ML

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unk.Date of event is 2020.Event day and event month were not reported.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during an unknown procedure, the extremity of the device pulled off from the staple rails.The device jaws were damaged during inserting the device into the trocar.It did not separate from the device shaft.It did not fall into the patient.It was not possible to put the device on the trocar.Another device was used to complete the procedure.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 4/2/2020.D4: batch # t94p1g.Investigation summary: the analysis results found that the el5ml device was received with one jaw disengaged from the cam.This condition would not allow the jaws to collapse in order to form the clips.No functional test was performed due the condition of the device.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.In addition, 6 clips were found inside clip track.Possible causes for the condition of the jaw being 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9838099
• MDR Text Key: 199082472
• Report Number: 3005075853-2020-01629
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 03/17/2020
• Patient Sequence Number: 1