MAUDE Adverse Event Report: GENICON, INC. GENICON GENISTRONG; NYLON SPECIMEN RETREIVAL BAG

Model Number 550-000-003

Device Problem Material Rupture (1546)

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

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The bags broke during use.

• Brand Name: GENICON GENISTRONG
• Type of Device: NYLON 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: 10400945
• MDR Text Key: 202714777
• Report Number: 3002590791-2020-00090
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: (01)00877972004004(10)I9731-H(11)180803(17)210802
• 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: 08/13/2020

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: 08/02/2021
• Device Model Number: 550-000-003
• Device Lot Number: I9731-H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• 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