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

Catalog Number MCM30

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2018.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: did the device completely fire? - unknown.Was the clip malformed or did an unformed clip fall from the device prior to firing the device? unknown.No further information is available.

Event Description

It was reported that device not working.Clicked, but not compressing ligaclip and then clip falling out when opened.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: 7747735
• MDR Text Key: 116250022
• Report Number: 3005075853-2018-11843
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002489
• UDI-Public: 20705036002489
• 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: 07/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: MCM30
• Device Lot Number: R40D6U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1