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

Model Number ER320

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 7/13/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: "vein has ruptured in liver and the case was switched from closed to open.The patient has experienced blood loss but now is in good condition and will be discharged in 2 days" "the case was switched to open and the bleeding was controlled in that way.I think 1 or 2 units of blood were given to the patient.The patient was in good condition when i last spoke.There was no negative situation.After 1-2 days of follow-up, the information was provided as the patient would be discharged.There was no negative return." 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, the device wasn't closing the veins, clips were fired cross and it caused bleeding.

Manufacturer Narrative

Pc-(b)(4).Date sent: 9/19/2023.

Manufacturer Narrative

(b)(4).Date sent: 8/13/2023.D4: batch # a9c658.Additional information was requested and the following was obtained: "the surgeon has mid-level experience with the device.The device wasn't fired on another clip.The vein rupture can be explained as, the clip didn't fully close the vein as it fired a cross clip, so the vein was harmed." 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 er320 device was received with the trigger broken.The device was disassembled to evaluate the condition of the internal components and the trigger was found broken, not allowing the clips to fed into the jaws.In addition, 6 clips were found remaining inside the clip track.Due to the condition of the device, no functional testing could be performed to evaluate the reported incident.The damaged on the device could be that the internal ribs were being gauged by the feeder link, causing the trigger to experienced additional force that could interfere with the firing of the device.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 batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 2/14/2024.A design analysis was performed.Definitive root cause is unable to be identified; however, no evidence of deformation or damage was found to the handle components, with the exception of the trigger.There were no issues related to the design or manufacturing of the device that would have caused the issue.

• 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: 17320844
• MDR Text Key: 319019293
• Report Number: 3005075853-2023-04915
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K864102
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: 298C83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention