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

Model Number 550-000-200

Device Problem Material Rupture (1546)

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

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.

Event Description

Doctor did one other case with the bag and it worked as expected.Crd mentioned another doctor had a tear (described in per 00576), and that doctor in this event also had a similar tear - at the seam toward the bottom or point of the bag.

• Brand Name: GENICON 2EZEE
• Type of Device: POLY SPECIMEN RETREIVAL 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 ; 6574851401
• MDR Report Key: 10387809
• MDR Text Key: 205330492
• Report Number: 3002590791-2020-00040
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)I9824-A(11)180911(17)200310
• 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: 08/10/2020

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: I9824-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 08/10/2020
• 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