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

Catalog Number MCM20

Device Problems Firing Problem (4011); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

The procedure was a left groin discectomy that was done on the (b)(6) 2018, the device is a ligaclip, code mcm20.The device was sticking and miss firing, the clips were not closing.A new device was opened to complete the procedure and there was no impact on the patient.I was not in the procedure when this happened.

Manufacturer Narrative

(b)(4).Batch # r93p2r.The analysis results found that the mcm20 device was received with no damage in the external components.In an attempt to replicate the reported incident, the device was cycled and one partially clip was formed due to an anti backup failure.The remaining 6 clips were fed and formed as intended.Finally, the instrument locked out.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the hoop spring and the anti-backup lever were found to be out of its intended position.No conclusion could be reached as to what may have caused the reported incident.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8088735
• MDR Text Key: 128045699
• Report Number: 3005075853-2018-14470
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: MCM20
• Device Lot Number: R40N74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 11/27/2018
• Patient Sequence Number: 1