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

Model Number 550-000-008

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during review of complaint files between october 2017 though december 2019.

Event Description

From per(b)(4) from pmi: "1- during usage of the specimen retrieval bag the strap attached to the handle broke while trying to remove it from the handle.2- while removing bag/specimen from body of patient the bag broke in half.Please note that while pulling the bag out the surgeon did stop half way to use a scalpel to morcellate the specimen for easier removal from the body.".

• Brand Name: GENICON GENISTRONG RETRIEVAL BAG, XL
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint court; suite 114; winter park, fl ; 6574851401
• MDR Report Key: 10377036
• MDR Text Key: 231723310
• Report Number: 3002590791-2020-00059
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 08/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: 550-000-008
• Device Lot Number: J0220-G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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