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

Catalog Number MCM20

Device Problems Failure to Form Staple (2579); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 10/5/2023.D4: batch # unk.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 liver resection procedure, had to fire three times for placement of one clip.The direction of the clip was right or left , so there was misalignment.Replaced the instrument and continue the operation.No patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 12/19/2023.Additional information was requested and the following was obtained: ""did the surgeon fire one device three times (clips fired right or left) and then changed to a second instrument, which worked well or did the surgeon used three different devices, where device one and two fired right or left clips and the third one worked well." answer: "the surgeon fire one device three times (clips fired right or left) and then changed to a second instrument, which worked well"" 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: "please clarify how the statement "the direction of the clip was right or left , so there was misalignment".Did the device feed slowly, sideways, or does not feed/advance into jaws? did the device multiple or double feed? did the device fire clips that are not formed completely or forms a pear/tear drop shape? did the device fire clips that the legs do not close parallel or cross? this may also include ribbon shaped or x-shaped.".

Manufacturer Narrative

(b)(4).Date sent: 11/9/2023.D4: batch # a9cv2t.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 the mcm20 device was received with no damage to the external components.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips, as a result, the instrument could no longer be fire due to the activation of the lockout mechanism.As the device was returned empty for evaluation we are unable to investigate further the issue of ¿malformed clips".The device was disassembled to verify the condition of the internal components and no anomalies were noted. the event described could not be confirmed as the device was returned empty.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 and lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 2/12/2024.D4: batch # unk.Upon receipt of additional information file is now a reportable malfunction.Additional information was requested and the following was obtained: "you mentioned that the surgeon encountered issues with one device before switching to a second, which worked properly.However, it appears that two devices were returned.One of these was presumably the one with which the surgeon encountered issues.What was the reason for returning the second device ¿ is this the device the surgeon switched to after encountering difficulties with the first one?" ¿the surgeon encountered same issues with both devices¿" 1.Type of reportable event 6.Medical device problem code.

• 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: 17879808
• MDR Text Key: 325030644
• Report Number: 3005075853-2023-07276
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCM20
• Device Lot Number: 442C45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/11/2023; 11/20/2023; 10/11/2023
• Supplement Dates FDA Received: 11/09/2023; 12/19/2023; 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1