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

Catalog Number EL5ML

Device Problems Failure to Form Staple (2579); Failure to Fire (2610); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Kidney or Urinary Problem (4503)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/8/2023.D4: batch # unk.Additional information was requested and the following was obtained: "today (18/07) sales rep received a call that due to reported problem the patient lost a kidney" 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 is the surgeons experience with this device? was each clip loaded into the jaws and visually inspected off of the target structure prior to firing? what was initial procedure? what anatomical structure was this device used on? how was bleeding controlled during the initial procedure? were any blood products given? if so, how much? how was the initial procedure completed? any videos of the surgical procedure that can be sent? we received additional information stating that "due to reported problem the patient lost a kidney".If re-operation, what was found at site? what was the indication for removing the kidney? please provide further detail of why the patient lost kidney.Please clarify why there is a belief that there is a correlation between the device and the patient losing a kidney." 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

During an unknown procedure, the staple did not completely close.This resulted in patient bleeding and losing approximately 800 ml of blood.

Manufacturer Narrative

(b)(4).D4: batch # (b)(6).This is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show a ligamax-5mm endo clip applier product code el5ml out of its packaging with a half-cycled trigger and a partially formed clip.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 9/6/2023.D4: batch # a9ce1p.Additional information was requested and the following was obtained: "what is the surgeons experience with this device? last 2 y, every lap cholecystectomies (400/y), was each clip loaded into the jaws and visually inspected of the target structure prior to firing? like always.What was the initial procedure? lap surrenalectomy left.What anatomical structure was this device used on? vena surrealist sinister.How was bleeding controlled during the initial procedure? hemolock.Were any blood products given? if so, how much? n/a.How was the initial procedure completed? laparoscopic.Any videos of the surgical procedure that can be sent? no.We received additional information stating that "due to reported problem the patient lost a kidney".If re-operation, what was found at site? no reoperation yet , conservative unless surinfection of the infarcted kidney , who has lost however all of its function.What was the indication for removing the kidney? not yet please provide further detail of why the patient lost kidney.Function yes, organ not yet.Please clarify why there is a belief that there is a correlation between the device and the patient losing a kidney.It is obvious that with a very short v surrenalis a trauma is difficult to solve.When solving the problem the instrument is again causing bleeding because of the ellips shape, you have to move more to the hilus.".

Manufacturer Narrative

(b)(4).Date sent: 10/24/23.

Manufacturer Narrative

(b)(4).Date sent: 11/20/2023.Additional information was requested and the following was obtained: "laparoscopic left surrenalectomy smooth start and progression of the procedure with mobilisation of the spleen angle colon, lateral spleen, pancreas and splenic vessels to medial.We fall on the fascia ven gerota, dissection of the medial gutter adrenal gland with attention to the vessels viz.V.Renalis and v.Surenalis.These are widely exposed for safe clipping.While placing the clips, bleeding occurs.Therefore, we place 2 additional clips proximally, without effect on the bleeding: 1 placed clip also falls off the vein, this clip is oval-shaped open.Also when piercing the blood vessel between the two clips (so that exposition becomes better to control the bleeding) bleeding increases as the placed clips do not close properly.We are forced to place hem-o-lok clip distally, this will bring bleeding under control.In toto about 850 ml of blood loss.We complete dissection around the adrenal gland to medial, lower edge and lateral to cranial.Finally remove the adrenal gland and end the procedure.With defective forceps, we try to shoot off some clips exvivo, after the procedure.The clips get stuck in the forceps for a while, when they come off they are not nice toe they take on an 'o' configuration.Postoperatively following persistent acute renal failure, a ct angio abdomen is performed on patient.On this, observation of stop image on the left arteria renalis 1.5 cm from the origin (also several surgical clips in this region, but not on the artery itself).Hypoperfusion kidney with development of renal infarction ultimately leads to a situation of 'unique kidney' and important health consequences for the patient.Procedure ii: lap cholecystectomy during multiple lap.Resections of the gallbladder, problems with the clip position of j&j were noted viz.Not closing the clip completely, legs of the clip being crossed." 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: "how many clips were applied to the patient during this surgery? how many clips were fired out prior to ¿non-formed¿ clip? how many in air and in patient? how many clips were fired out after ¿non-formed¿ clip? how many in air and in patient? did the surgeon visually confirm each clip was fully formed after applying to the vessels? did the surgeon fully squeeze the trigger until it stops against the handle for each firing? was there any movement during firing and after the clip was partially formed, that caused clip displacement from the jaw prior to fully forming? did the surgeon use the anti-backup function? (trigger partially squeezed and held position to regrip trigger) was the clip in the image removed from the body? was this clip on the vessel when removed or laying within the body cavity? were the clips formed properly when firing test clips into packaging tray? were there any malformed clips when firing out test clips into packaging tray? how many clips remain in the device at this time? is the clip count window at the top of the device white, partial orange or full orange? the clip in the image appears to have been partially formed.Was the clip confirmed to still be in the jaws when finishing the trigger stroke / full formation of the clip? did the trigger lockup during the surgery or testing of the device? did the trigger lockup during the application of the ¿non-formed¿ clip or test clip? did the trigger lockup by not returning to the full open position or did it lockup by preventing full squeezed stroke? is there a clip still in the jaws in the current locked-up state? how soon after surgery, was device tested? how many hours after the surgery? was there dried blood within the jaws of the device when testing? do you have all test clips retained and available? any odd sounds or rough feeling during the trigger stroke / forming of the clips?".

Manufacturer Narrative

(b)(4).Date sent: 1/16/2024.D4: batch # a9ce1p.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 original packaging unopened 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 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.The event described could not be confirmed as the device performed without any difficulties noted.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Device history lot: null.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/23/2024.Correction: h6.Type of investigation h6.Type of investigation.

• 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: 17481836
• MDR Text Key: 320609776
• Report Number: 3005075853-2023-05584
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Device Lot Number: A9CE1P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability