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

Model Number	550-000-005
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaints received between (b)(6) 2017 and (b)(6) 2019.A root cause of the broken bag could not be determined from the review of production records and without the actual device to examine.
Event or Problem Description
Specimen retrieval bag broke while removing specimen from the patient during a lobectomy.

• Brand Name: GENISTRONG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 10253562
• Report Number: 3002590791-2020-00035
• Device Sequence Number: 19441069
• Product Code: GCJ
• UDI-Device Identifier: 00877972005186
• UDI-Public: (01)00877972005186(10)I8838(11)171110(17)201109
• 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): 07/09/2020

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: No Information
• Device Expiration Date: 11/09/2020
• Device Model Number: 550-000-005
• Device Lot Number: I8838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1