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 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When attempting to utilize the bags, the bags tore upon removal through the defect.Tears were at the bottom of the bag on 3 of the bags.A new bag was used each time.A different bag tore apart into multiple pieces.As a result the scrub tech had to piece the bag back together on the back table to ensure all the pieces were removed from the patient's abdomen.Facility cannot locate bags for return.

• 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: 10402026
• MDR Text Key: 202755335
• Report Number: 3002590791-2020-00099
• 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: 08/13/2020

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: 12/04/2020
• Device Model Number: 550-000-200
• Device Lot Number: J0468-B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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