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

Model Number	550-000-003
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaints received between october 2017 and december 2019.Based on no sample provided, the root cause of the complaint could not be determined.Without a physical evaluation of the device it is not possible to determine the origination point of the break or the root cause of the break.
Event or Problem Description
Specimen retrieval bag broke at its seam.Surgeon spent considerable time extracting, adding 1.5 hour to the case.

• 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: 10243045
• Report Number: 3002590791-2020-00026
• Device Sequence Number: 18966749
• 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: Not provided
• 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