MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number	LT400
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2018.As a lot/batch was not provided, a device history could not be performed.The following information was requested and the following was obtained: was the clip fired on tissue, but detached from the tissue? clips were not closed as intended.Was the clip malformed? the clips didn¿t close and slided away from the vessel.Was there any patient consequence? no.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.What applier was being used? can you please confirm whether or not the account was using the lc800 clip cartridge base when there were loading the clips from the cartridge?.
Event or Problem Description
After the application the clip detached.The issue was solved using new one.

• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7646936
• Report Number: 3005075853-2018-11010
• Device Sequence Number: 2435925
• Product Code: FZP
• UDI-Device Identifier: 20705036012839
• UDI-Public: 20705036012839
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LT400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/28/2018
• Patient Sequence Number: 1