MAUDE Adverse Event Report: GENICON, INC. GENICON ALI-GATOR; APPLIER, HEMOSTATIC CLIP

Model Number	360-010-001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information provided regarding impact or consequence to the patient (2692).Through clinical simulation with a retained sample (11), as well as through evaluation of the actual/suspect device (10), the staples jamming in the clip applier (1384) relates to firing the handle too fast and causing an interlock (61).When the device interlocks, the clip cannot be sent to its correct position for application (3213).Attempting to apply the clip in an incorrect positon will result in unshaped clips.A historical review of complaints (4109) determined no other complaints of this nature have been reported.
Event or Problem Description
This report summarizes a previously unreported malfunction.The distributor reported that the doctor was unable to clip the vessel and duct (of a patient and during surgery) due to staples jamming in the clip applier.

• Brand Name: GENICON ALI-GATOR
• Common Device Name: APPLIER, HEMOSTATIC CLIP
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct; suite 114; winter park, fl
• MDR Report Key: 9803325
• Report Number: 3002590791-2020-00002
• Device Sequence Number: 19027324
• Product Code: HBT
• UDI-Device Identifier: 00877972006343
• UDI-Public: 00877972006343
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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 Model Number: 360-010-001
• Device Lot Number: I8251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1