MAUDE Adverse Event Report: GENICON, INC. GENICON A LI-GATOR SINGLE-USE MULTI-FIRE CLIP APPLIER, 10 MM

Model Number	360-010-001
Medical Device Problem Codes	Misfire (2532); Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between october 2017 through december 2019.
Event or Problem Description
Doctor was doing a case he preloaded the clipper before use and fie 1st clip nothing came out, then he tried 2nd time and x2 clips came out and the jaws of the clip cut off the arteries.Clipper was checked and "was still loaded, the hand piece is jammed.".

• Brand Name: GENICON A LI-GATOR SINGLE-USE MULTI-FIRE CLIP APPLIER, 10 MM
• Common Device Name: SINGLE-USE MULTI-FIRE CLIP APPLIER
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10385394
• Report Number: 3002590791-2020-00060
• Device Sequence Number: 1725659
• Product Code: GDO
• UDI-Device Identifier: 00877972006343
• UDI-Public: (01)00877972006343(10)J0228-A(11)190420(17)220419
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K030269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: 360-010-001
• Device Lot Number: J0228-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1