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

Catalog Number MCM20

Device Problems Failure to Form Staple (2579); Failure to Fire (2610); Difficult to Open or Close (2921)

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported that during a cardiovascular surgery, the handle did not open after several firings.The handle was opened by manual override lever and was fired again however the handle did not open again.The handle did not open, and the jaws was opened suddenly, and the clip fell off after a few minutes later.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 4/17/2024.D4: batch # x7038u.Additional information was requested and the following was obtained: "please provide more information to the case.Jaw could not be opened.When the jaw was opened, the clips fell down.Jaw could not be opened on the tissue.After the surgeon forced it, he could open it.When he tried to open it outside the surgery, he could open it with force,but the clip fell off.There was no effect on the patient.The procedure was cabg and the device was used on the great saphenous vein there was no bleeding and no tissue damage after clipping on blood vessel, the jaws did not opened and were manually released.There were no problems with clip formation.The patient is stable after the operation" 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 mcm20 device was returned with a clip in jaws and with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining eleven(11) clips as intended; however the handles do not return to its original open position by then self.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling no anomalies were noted.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19124728
• MDR Text Key: 340380268
• Report Number: 3005075853-2024-02978
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• 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: X7038U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1