MAUDE Adverse Event Report: GENICON ALI GATOR; DISPOSABLE CLIP APPLIER

Model Number 360-010-001

Device Problems Component Falling (1105); Mechanical Problem (1384); Failure to Form Staple (2579)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Genicon determined the issue stemmed from the plastic not molding correctly.A review is underway.

Event Description

The genicon ali gator, disposable clip applier, is preloaded with 20 m/l titanium clips.During the procedure, one of the clips fell into the patient without closing.The doctor then attempted to seal the duct and used nineteen of the twenty clips.In total, fifteen clips fell into the patient and four were placed as intended.

• Brand Name: ALI GATOR
• Type of Device: DISPOSABLE CLIP APPLIER
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer (Section G): GENICON, INC; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer Contact: katlyn kachman ; 6869 stapoint court; suite 114; winter park, FL 32792 ; 4076574851
• MDR Report Key: 7314260
• MDR Text Key: 101842986
• Report Number: 3002590791-2017-00002
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: 360-010-001
• Device Catalogue Number: 360-010-001
• Device Lot Number: I8251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1