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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that during a left total nephrectomy/coelio.There were faulty clips; the clips cross and cut: risk of arterial injury.No patient consequences reported.No further information is available.

Manufacturer Narrative

(b)(4).Batch # unk.Event: date of event unknown.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Attempts have been 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm, was there any issue with bleeding? if yes, how was the bleeding controlled? what amount of blood loss (mls) occurred? was a transfusion required? was there any change to the procedure as a result of the event? what is the current patient status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 4/13/2022.Additional information was requested, and the following was obtained: please confirm, was there any issue with bleeding? not significant bleeding.If yes, how was the bleeding controlled? it was controlled by controlled using fenestrated forceps allowing compression of the artery, its extensive dissection and placement of a hemoloc.It was a small caliber artery ; the consequences could have been very serious if the artery was of a larger caliber.What amount of blood loss (mls) occurred? not significant.Was a transfusion required? no.Was there any change to the procedure as a result of the event? no.What is the current patient status? the patient goes well.No patient consequence.

Manufacturer Narrative

(b)(4) date sent: 5/19/2022 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 revealed that the el5ml device was returned with no apparent damage.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 7 conforming clips.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, 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.Do not insert the clip applier through a trocar if a clip is present in the jaws.This may result in clip malformation, dislodged clips, or damage to the instrument.If a clip is present in the jaws, fully squeeze the trigger against the handle, then fully release the trigger to release the clip from the jaws before inserting the device through the trocar.The event described could not be confirmed as the device performed without any difficulties noted.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13763216
• MDR Text Key: 287808767
• Report Number: 3005075853-2022-01552
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 05/19/2022

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: V96722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/23/2022; 04/28/2022
• Supplement Dates FDA Received: 04/13/2022; 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1