MAUDE Adverse Event Report: GENICON, INC. A LI-GATOR; SINGLE-USE LAPAROSCOPIC CLIP APPLIER

Model Number 360-010-001

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files received between (b)(6) 2017 and (b)(6) 2019.The dimension between the steel disc, which is used for pressing staples, and the cartridge's covering plate did not match well, which caused the staple stuck problem.A repair to the tooling of the steel disc was completed and problem resolved.

Event Description

Ligation clips were shooting out of the jaws of the clip applier during a lap chole procedure.

• Brand Name: A LI-GATOR
• Type of Device: SINGLE-USE LAPAROSCOPIC CLIP APPLIER
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 10250256
• MDR Text Key: 202256062
• Report Number: 3002590791-2020-00031
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K030269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2020
• Device Model Number: 360-010-001
• Device Lot Number: I8252
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2017
• 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