MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER420

Device Problems Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # x94g0z.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 er420 device was returned with no damage in the external components. upon cycling, the device was noted to be empty and the lockout had been fired through. the instrument was disassembled in order to evaluate the condition of the internal components and the latch posts were noted to be broken, which denotes that the lockout had been fired through.Due to the condition of the device, no functional testing could be performed to evaluate the reported incident.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Please note the device contains a lockout feature that is designed to increase the required force it takes to close the trigger once the last clip has been fired; this reduces the possibility of empty jaws being closed on a structure.

Event Description

It was reported that during a laparoscopic procedure, the clips were fired/ used to clip the cystic artery but did not fully engage.The clip didn't fully close and engage.Just the tip closed/engaged (often used in cholangiogram cases).Surgeon didn't notice at the time so continued to cut the cystic artery.The artery began to bleed immediately and as they couldn't control the bleed laparoscopically, they proceeded to open the patient and perform a laparotomy.At first staff thought it was just that clip applicator with a fault so didn't do anything.Used the same batch number for next case taking care to check that the clips were fully engaged.Realized that there was an error with this clip applier as well.Used clip appliers with different batch/lot number for the rest of the list with no problems.Consequences for the patient was a laparotomy performed and all other complications associated with having a laparotomy over a laparoscopy procedure.The patient lost approximately 2 liters of blood.Unsure of post of consequences and implications on patient's outcome.

Manufacturer Narrative

(b)(4).Date sent: 11/9/2022.Additional information was requested and the following was received: "please describe what is meant by the clip did not fully engage? the clip did not fully close together across the whole length.Describe the shape of the clip? x shape.Was the device fired plastic to plastic? yes.Did the user ensure the jaws were unobstructed prior to firing? yes.Was the clip fully advanced and visualized in the jaws prior to firing? yes.How many clips exhibited the behavior? one or more than one clip? 4 clips.How was the case completed? the case was completed without any other adverse advents once the bleed from the cystic artery was stopped.The bleed could not be stopped laparoscopically so a laparotomy was performed.Was there any change in the patient¿s post-operative care as a result of this issue? extra wound care due to the laparotomy.What is the current patient status? the patient is still very distressed over the incident and is yet to return to work.The patient seeks an explanation and is receiving treatment for ongoing pain and discomfort to include physiological therapy.".

• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15196276
• MDR Text Key: 297570217
• Report Number: 3005075853-2022-05183
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: X94H15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention