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

Model Number	550-000-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.
Event or Problem Description
This facility is converting to our bags.This was the 1st time this surgeon has used our bags.When he pulled the gallbladder out of the port w/ moderate/strong force the bag burst.He did everything correctly as i witnessed.He was in-serviced on this product and i was there to walk him through the proper use of this tissue bag.The bag was not punctured by any instruments.The bag seemed to tear at the cinch string area opening.

• Brand Name: GENICON 2EZEE
• Common Device Name: POLY SPECIMEN RETREIVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10372677
• Report Number: 3002590791-2020-00062
• Device Sequence Number: 16938313
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0562-B(11)190702(17)210101
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 01/01/2021
• Device Model Number: 550-000-200
• Device Lot Number: J0562-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1