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	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files received between (b)(6) 2017 and (b)(6) 2019.No physical or visual evaluation could be performed; complainant did not take photographs and did not keep the sample for return.A root cause could not be determined.
Event or Problem Description
The rip-stop nylon strip containing cinching string came detached from the specimen retrieval bag and point of connection to the bag.The specimen retrieval bag fell into patient's abdomen and was retrieved by the surgeon using a grasper.

• 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: 10243044
• Report Number: 3002590791-2020-00028
• Device Sequence Number: 18966748
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: (01)00877972004004(10)I9074(11)170111(17)201010
• 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: 10/10/2020
• Device Model Number: 550-000-003
• Device Lot Number: I9074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2018
• 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