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

Model Number 550-000-003

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 02/13/2018

Event Type  malfunction  

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 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
• 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: 10243044
• MDR Text Key: 200838529
• Report Number: 3002590791-2020-00028
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972004004
• UDI-Public: (01)00877972004004(10)I9074(11)170111(17)201010
• 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: 10/10/2020
• Device Model Number: 550-000-003
• Device Lot Number: I9074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1