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

Model Number EL5ML

Device Problems Failure to Fire (2610); Difficult to Open or Close (2921); Firing Problem (4011)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4); batch #: unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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 an unknown procedure, the surgeon tried to fire el5ml through pull of the trigger but clip didn't fire.When surgeon released the trigger, jaw didn't open though trigger was released.It feels stiff.It is unknown how procedure was completed.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Date sent: 12/16/2020.D4: batch # u9324c.H6: component code: mechanical (g04).Investigation summary: the analysis results found that the el5ml device was received with the firing trigger jammed and with the jaws in closed position.No functional test was performed due the condition of the device.In order to evaluate the device¿s internal components, the instrument was disassembled.Upon disassembling of the device, the ratchet pawl was found damaged causing the trigger jammed.Five clips were found inside clip track.No conclusion could be reached as to what may have caused ratchet pawl damage.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: do not excessively twist or torque the instrument jaws when positioning or firing the instrument on a tubular structure or vessel.Excessive twisting or torquing may result in clip malformation." it should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.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: 10837021
• MDR Text Key: 216158006
• Report Number: 3005075853-2020-05984
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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
• Device Lot Number: U93204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/01/2020
• Patient Sequence Number: 1