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

Model Number EL5ML

Device Problem Failure to Form Staple (2579)

Patient Problems Failure to Anastomose (1028); Peritonitis (2252)

Event Date 11/25/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).Batch #: x95a21.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: "were there any difficulties with the device and/or clip formation during the initial procedure? does the surgeon visualize the loading of the clip, off of the vessel, into the device jaws before applying to the vessel and firing? during reoperation it was stated that the surgeon ¿observed that the clips were not properly closed¿, could you please describe the shape of the clips? does the surgeon believe the peritonitis resulted from the biliary leak or from other pathology noted in the gastrointestinal tract during reoperation? does the surgeon believe that the patient¿s demise was due to an alleged deficiency of the device or other continuous factors, to include patient tissue condition? could you please provide the patient age, gender, and bmi? did the patients demise occur during the reoperation? if no, when did it occur? what was the patients cause of death?".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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic cholecystectomy, there was initially nothing to report.Four days after the intervention, the patient was recovered by the surgeon because of a deterioration of the patient's condition.When re-operating on the patient, the surgeon found the bile duct clips in place.However, no sooner had the surgeon touched them, they slipped away as if they did not fit.It was observed that the clips were not properly closed.The canal was not thick and the first clips placed on the artery were perfectly closed.Death of the patient.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2023.D4: batch # x95a21.Additional information was requested and the following was obtained: "our failure analysis lab received 5 extra products with reference to this complaint.It is noted in your response to previous follow up that, "these same clips were sent to you by dhl and you received them on friday december 16, with 2 boxes of ligamax el5ml from the same lot, which the pharmacist had quarantined." please confirm the number of products involved with this event? if not all 6, do you know which product sent was involved in the procedure? only 1 device is involved in this complaint.But the impacted device is not available.Only the clips are available and sent by the customer.Were there any difficulties with the device and/or clip formation during the initial procedure? no, the first clips placed (those of the bladder artery) were done correctly, and they were in place and perfectly closed and stable when surgeon re-operated the patient.Does the surgeon visualize the loading of the clip, off of the vessel, into the device jaws before applying to the vessel and firing? it is not a vessel but the cystic duct during a laparoscopic gallbladder removal.Given surgeon experience, i think so, but you'll have to ask him to be completely sure.During reoperation it was stated that the surgeon ¿observed that the clips were not properly closed¿, could you please describe the shape of the clips? attached you will find the photo of the clips of the cystic duct that surgeon recovered from the patient.These same clips were sent to you by dhl and you received them on friday december 16, with 2 boxes of ligamax el5ml from the same lot, which the pharmacist had quarantined.Does the surgeon believe the peritonitis resulted from the biliary leak or from other pathology noted in the gastrointestinal tract during reoperation? during an informal interview that we had, surgeon told me that he thinks that the peritonitis results from the bile leak caused by the two poorly closed clips.The bile leak must have, i quote, ¿be very quiet, which explains why her condition only worsened late (the patient was re-operated on d4)¿.Does the surgeon believe that the patient¿s demise was due to an alleged deficiency of the device or other continuous factors, to include patient tissue condition? i believe the surgeon believes the device failure contributed to the patient's death.It has never been formal and is expressed with all the usual scientific precautions.Did the patients demise occur during the reoperation? if no, when did it occur? no, the patient died shortly after the reoperation.But i don't know exactly how long.What was the patients cause of death? peritonitis.I don't have more details." 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 only two malformed clips were returned inside a plastic bag.We were unable to analyze the sample utilized in the reported event as the el5ml instrument was not returned to us.No conclusion could be reached on the cause of the reported event.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.

Manufacturer Narrative

(b)(4).Date sent: 2/10/2023.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 inside it's packaging unopened with no apparent damage.In addition, two malformed clips were returned inside a plastic bag 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 15 conforming clips.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.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.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16022831
• MDR Text Key: 305891044
• Report Number: 3005075853-2022-08861
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: X95A21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Female