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)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device with lot number and no non-conformances were identified.Attempts are being made to retrieve the device.To date, the device has not been returned.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 distal gastrectomy, the device was locked out, and the jaws became not to open with the target tissue clamped at the second firing on the left gastroepiploic vein.The tissue was cut by the harmonic to remove the device.No leakage was observed.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).Date sent: 12/15/2020.D4: batch # u94z0d.H6: component code: mechanical (g04).Investigation summary: the analysis results found that the el5ml device was received with no damage to the external components.During the analysis, the device was cycled and it fed and formed one scissored clip and then eleven conforming clips were fed and formed.In addition, the instrument did not lock out.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 anti-backup failure.In addition, the closure link roller was noted damaged.Although it is not possible to conclude how the circumstances occurred, it is known from the history of the instrument that an incorrect/excessive application of torque to the jaws during instrument use creates a misalignment of the tips.As no conclusion could be reached on what caused the ratchet pawl and link roller to become damaged.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: firing the instrument over another clip or instrument can also damage a properly deployed clip, disrupt related vessels and structures, and damage the instrument." additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: 10865140
• MDR Text Key: 217179748
• Report Number: 3005075853-2020-06119
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: U94Z0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 11/24/2020
• Patient Sequence Number: 1