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

Model Number MCL20

Device Problems Failure to Form Staple (2579); Failure to Fire (2610); Mechanical Jam (2983); Mechanics Altered (2984)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the clip appliers did not release properly, the clip snagged and the vessel was injured.No patient consequences.

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "please provide more details about statement: ¿clip pliers did not release properly, the clip snagged and the vessel was injured.¿ did device not feed clips? yes.Did device feed clips sideways? did device not fire clips (jammed)? yes.Did device fire malformed clips? yes.Did device fire scissored clips? did jaw cut the vessel? yes.Did clip cut the vessel? if other, please specify".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 any bleeding occur? did the patient need to have a blood transfusion? if yes, how much blood did the patient require? did the patient need any different type of post op care due to the perceived jaw cutting?".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.

Manufacturer Narrative

(b)(4).Date sent: 3/17/2023.D4: batch # x9557p additional information was requested and the following was obtained: "did any bleeding occur? yes, amount cannot be quantified.Did the patient need to have a blood transfusion? not relevant for the assessment of the rejected products.If yes, how much blood did the patient require? not relevant for the assessment of the rejected products.Did the patient need any different type of post op care due to the perceived jaw cutting? not relevant for the assessment of the rejected products.Note body (local language).Aei received date".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 mcl20 device was returned with no damage to the external components.In addition, the packaging opened was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the trigger could not be completely activated due to the firing mechanism was jammed.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the lockout spring was found to be out of its intended position, jamming the firing mechanism.17 clips were found inside clip track.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met prior to the release of this batch.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.

• 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: 16375133
• MDR Text Key: 309565990
• Report Number: 3005075853-2023-00981
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002468
• UDI-Public: 10705036002468
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K820837
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCL20
• Device Catalogue Number: MCL20
• Device Lot Number: 855A45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1