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

Model Number	550-000-008
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Ring came off as the doctor pulled bag into the shaft.The event was associated with one (1) genistrong specimen retrieval bag, extra large (product code 550-000-008).Delay in procedure, but there was no patient harm.

• Brand Name: GENISTRONG, SPECIMEN RETRIEVAL BAG. EXTRA LARGE
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10315180
• Report Number: 3002590791-2020-00078
• Device Sequence Number: 3462742
• Product Code: GCJ
• UDI-Device Identifier: 00877972005919
• UDI-Public: 00877972005919
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 07/23/2020

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: 11/16/2020
• Device Model Number: 550-000-008
• Device Lot Number: I8839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1