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

Model Number EL5ML

Device Problems Failure to Fire (2610); Mechanics Altered (2984); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sigmoidectomy, the clip could not be fed into the jaw properly.The device was fired without clip fed properly, so the oozing occurred.The device was used on the blood vessels.The device was removed, and the clip came out when the device tip was shaken.Another device was used to complete the case.No patient consequences.

Manufacturer Narrative

(b)(4).Batch # x96225.Additional information was requested and the following was obtained: "semi-opened which it was planned to open it later, and sutured to hemostasis.The patient is stable after the operation." "did the patient need modified post op care due to the oozing? no.It is stated that the procedure was "semi-opened which it was planned to open it later".Was the procedure originally planned to be converted to open or was it converted to open because of the oozing that occurred? the procedure originally was planned to be converted to open." investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was received with no damage to the external components.In addition, the tyvek was returned along with the instrument.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips, as a result, the instrument could no longer be fire due to the activation of the lockout mechanism.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.The instrument has an orange indicator that appears on the top of the handle as a reference for the user as to the number of clips remaining.The event described could not be confirmed as the device was returned empty.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: when the 13th clip is fired, an orange bar will begin to appear in the indicator window on top of the device handle.The orange bar fills the indicator window when the final clip is fired.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16327132
• MDR Text Key: 309127838
• Report Number: 3005075853-2023-00875
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2023

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: X96225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1