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

Model Number	550-000-005
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
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.The device was returned to genicon for evaluation, however one photograph was provided.
Event or Problem Description
Bag broke during robotic lobectomy.See picture.According to information obtained by rep, the bag broke while the specimen was inside the chest cavity and they were trying to pull it out.A 10 inch incision was made on patient's chest to remove specimen.(b)(6).
Additional Manufacturer Narrative
Updated b4 with current date of this report, d2 corrected typographical error in word "retrieval"), g7 (noted follow up and 001), h2 noted "correction" as follow up type, corrected h10 (manufacturer's narrative) to clarify that "the device was not returned to genicon for evaluation.".

• Brand Name: GENISTRONG SPECIMEN RETREIVAL BAG, LARGE
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10362739
• Report Number: 3002590791-2020-00063
• Device Sequence Number: 19415648
• Product Code: GCJ
• UDI-Device Identifier: 00877972005186
• UDI-Public: (01)00877972005186(10)I9410-J(11)18511(17)210510
• 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,Followup
• Report Date (Section B): 08/11/2020

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: 05/10/2021
• Device Model Number: 550-000-005
• Device Lot Number: I9410-J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1