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

Catalog Number EL5ML

Device Problem Failure to Form Staple (2579)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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.What was done to address the tissue that was cut? how was the procedure completed? were there any patient consequences? the number you provided, p00019p67, is not a valid batch and/or lot number.Do you have the six digit/character batch and/or lot number for the device?.

Event Description

It was reported that during a laparoscopic cholecystectomy, when trying to use the ligamax stapler, it was noted that it did not work properly.When stapling the staple, it is released closed and cuts the tissue.

Manufacturer Narrative

(b)(4).Batch # r95669.Additional information was requested, and the following was obtained: demographic data of the patient (initials starting with surname, age at the time of surgery, gender) female.Was there any damage / consequence in the patient due to a problem with the product? yes, the ligamax was able to cut the artery with the jaw closed and the cystic.Was there a surgical delay due to the problem presented with the product? yes, 30 min.Does the doctor consider that the delay could have caused death or serious injury or harm to the patient? if yes, explain the risk assessed by the doctor.Yes, it caused the patient a hematoma and was hospitalized 2 more weeks.Address of the (b)(6) hospital - (b)(6).What action did the doctor take to correct / correct the problem presented with the device? el used another device, i do not know if it was another lot.What is the current state of the patient? discharge without consequences device analysis: the analysis results found that the el5ml device was returned with no damage in the external components.In addition, the tyvek was returned along with the instrument.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 1 conforming clip.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.No conclusion could be reached as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot r95669 number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch r95669 number, and no non-conformances were identified.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.Did the surgeon load and inspect the jaws for clip presence off vessel prior to attempting to placing on structure? does the surgeon believe that the damage that was done was done by the clip or by empty device jaws? how was the hematoma identified? how was the hematoma addressed? why was the patient hospitalized for 2-weeks?.

• 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: 8731357
• MDR Text Key: 149216181
• Report Number: 3005075853-2019-20041
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: R95669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Date Manufacturer Received: 07/05/2019
• Patient Sequence Number: 1