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

Model Number	550-000-003
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable incident was identified during a review of complaints received between october 2017 and december 2019.No sample was provided for evaluation.Without a physical evaluation of the device, it is not possible to determine the origination point of the bag break or the root cause of the bag break.
Event or Problem Description
During a lap cholectomy, the genicon specimen bag was used through a 12mm lap port.The gallbladder was collected with the bag.The correct technique was used to close the bag.The port was pulled out of the patient.The genicon bag was being pulled out of the patient by the string when it was torn in half.The gallbladder had several small and large stones in it which then were scattered back into the abdomen of the patient and throughout the layers of tissue of the abdominal wall.A picture of the broken device inside the abdomen is available.

• 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: 10243042
• Report Number: 3002590791-2020-20029
• Device Sequence Number: 535843
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: (01)00877972004004(10)I8828(11)170911(17)200910
• 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): 07/07/2020

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: 09/10/2020
• Device Model Number: 550-000-003
• Device Lot Number: I8828
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1