MAUDE Adverse Event Report: GENICON GENISTRONG; SPECIMEN RETRIEVAL BAG

Model Number	550-000-005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The end of the device was cracked, which wouldn't allow it to fit into the trocar.It has to be able to pass through the trocar to enter into the patient.
Additional Manufacturer Narrative
Genicon has completed a thorough review of all available records related to this device and associated lot numbers.Records indicate that these lots passed all manufacturing and quality control inspections.All raw materials used passed incoming quality control checks and no irregularities or abnormalities were found.Review of vigilance reports did not reveal any trends, with respect to an increase in frequency or a trend to a specific lot.The suspect device was able to be retained and shipped to genicon for evaluation.A thorough evaluation of the returned device was completed by engineering, indicating the device was retuned with the distal end of the introducer flared outward.Device design and subsequent testing has established that the flaring of the introducer tube does not impact the device performance.The flare aids in retraction of the bag and inhibits that potential for the introducer to fracture.Given the compliant nature of the introducer, introduction down an appropriate size cannula is accomplished within the specified performance limits.The narrative indicated this device was not able to be used, however testing has revealed that flaring of this nature/degree only appears after a significant number of uses.Therefore it may have been the case that this device was attempted to be retracted several times, but never actually used.It is important to note that during retraction of the bag air will build up and become caught.This air can be exhausted from the bag by squeezing the still deployed end as shown in the instructions for use to aid is easier bag retraction.Care should be taken to follow all warnings, precautions and directions detailed in the instructions for use to ensure the highest level of safety and patient care.Genicon will continue to monitor this issue through our vigilance system for trends and take appropriate actions as necessary to ensure the continued performance and safety of the product.
Event or Problem Description
End of the device was cracked which wouldn't allow it to fit into the trocar.It has to be able to pass through the trocar to enter the patient.

• Brand Name: GENISTRONG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• MDR Report Key: 9232837
• Report Number: 9232837
• Device Sequence Number: 13555784
• Product Code: GCJ
• UDI-Device Identifier: 00877972005186
• UDI-Public: (01)00877972005186(10)9411J(11)190109(17)220108
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019
• Report Date (Section F): 10/07/2019

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: 01/08/2022
• Device Model Number: 550-000-005
• Device Lot Number: I9411-J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/07/2019