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 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Lap chole case with the doctor using the new 550-000-200 bag at the hospital.The customer said several doctors complained about the quality of the original poly bag, and previously had 2 torn bags but they did not note the item or lot numbers.So we converted to the new bags in an attempt to save the account.In the first case while trialing the new genicon bag, the bag tore while trying to remove from patient.The tear was near the bottom of the bag, and the stone fell back into the abdomen.

• 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: 10387875
• MDR Text Key: 205131443
• Report Number: 3002590791-2020-00053
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0408-B(11)190510(17)221109
• 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 a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 550-000-200
• Device Lot Number: J0408-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2019
• 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