MAUDE Adverse Event Report: GENICON, INC. GENICON 2EZEE POLY SPECIMEN RETRIEVAL BAG

Model Number 550-000-200

Device Problem Material Rupture (1546)

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

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between october 2017 through december 2019.

Event Description

(b)(4)."2ezee used on a robotic case.All went well until it was time to pull out the specimen.Hard to pull out the bag burst and a gencion bag with a nylon bag was used to complete.During robotic vat procedure using genicon 2ezee as trial, while the device was being withdrawn, the bag stretched and eventually burst.Using genicon bag with reinforced nylon, the procedure was completed.".

• Brand Name: GENICON 2EZEE POLY SPECIMEN RETRIEVAL BAG
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10374255
• MDR Text Key: 245203813
• Report Number: 3002590791-2020-00057
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180836
• 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: 08/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2020
• Device Model Number: 550-000-200
• Device Lot Number: I9845-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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