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

Model Number	550-000-200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is for first device reported in the complaint.
Event or Problem Description
Doctor was performing gallbladder surgery, and the 550-000-200 bag burst at the bottom during removal.He used two additional bags during same surgery with the same result.The procedure was finished with a fourth genicon bag.No harm to patient.Bags were discarded.The site was not enlarged and the port site was 10 mm.Note: this mdr is for the 1st 500-000-200 specimen retrieval bag listed in the complaint.

• Brand Name: 2EZEE
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 10727196
• Report Number: 3002590791-2020-00107
• Device Sequence Number: 3025732
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0719-B(11)191003(17)210402
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2021
• Device Model Number: 550-000-200
• Device Lot Number: J0719-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1