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

Catalog Number MCM20

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.A manufacturing record evaluation was performed for the finished device lot number r40c1p, and no non-conformances were identified.Additional information was requested, and the following was obtained: just for clarification, can you please confirm if the device fired malformed or unformed clips? if yes, were they not able to hold onto the vessel they were applied to? or did the clips drop or eject unformed clips from the jaws? r= the device fired malformed clips which were unable to hold on the vessel.

Event Description

It was reported that during a discectomy, the surgeon used the ligaclip on a vessel, but the clips didn¿t have strength to grasp and fell out.No delay in the procedure.Opened another ligaclip to complete the case successfully.Fragments were generated and removed easily without intervention.There were no patient consequences.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8439663
• MDR Text Key: 139562600
• Report Number: 3005075853-2019-17434
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: MCM20
• Device Lot Number: R40C1P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1