MAUDE Adverse Event Report: GENICON, INC. GENICON A-LI-GATOR CLIP APPLIER

Model Number	360-010-001
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.
Event or Problem Description
The disposable clip applier a li-gator jammed and the doctor could not continue to use the clip applier.The event was a colelap for a male patient.In that procedure there was no injury to the patient and there was a delay in procedure but that not impact patient safety.

• Brand Name: GENICON A-LI-GATOR CLIP APPLIER
• Common Device Name: CLIP APPLIER
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 10504866
• Report Number: 3002590791-2020-00104
• Device Sequence Number: 3182807
• Product Code: GDO
• UDI-Device Identifier: 00877972006343
• UDI-Public: 00877972006343
• Combination Product (Y/N): N
• Initial Reporter Country: VE
• PMA/510(K) Number: K030269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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 Expiration Date: 05/17/2022
• Device Model Number: 360-010-001
• Device Lot Number: J0243-A
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1