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

Model Number 550-000-003

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 02/06/2018

Event Type  malfunction  

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 Description

Specimen retrieval bag broke at its seam.Surgeon spent considerable time extracting, adding 1.5 hour to the case.

• Brand Name: GENISTRONG
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 10243045
• MDR Text Key: 199889441
• Report Number: 3002590791-2020-00026
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: (01)00877972004004(10)I8828(11)170911(17)200910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: 550-000-003
• Device Lot Number: I8828
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1