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

Model Number	550-000-003
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between october 2017 through december 2019.
Event or Problem Description
The bags broke during use.

• Brand Name: GENICON GENISTRONG
• Common Device Name: NYLON SPECIMEN RETREIVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10400945
• Report Number: 3002590791-2020-00090
• Device Sequence Number: 11513051
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: (01)00877972004004(10)I9731-H(11)180803(17)210802
• 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): 08/13/2020

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: 08/02/2021
• Device Model Number: 550-000-003
• Device Lot Number: I9731-H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1