MAUDE Adverse Event Report: GENICON, INC. GENICON 2EZEE SPECIMEN RETRIEVAL BAG

Model Number 550-000-200

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.

Event Description

This was the very first case done with new bag.It was done late in the evening and i was not present.All staff was in-serviced.Bag ruptured as bottom as specimen was being extracted.I was told that or is "in an uproar" because we told them this bag is stronger and should not burst wtih normal usage.First case, it burst.The bag was used in a normal way- specimen was normal.Bag ripped at distal tip.A total of 3 genicon bags were opened and used to retrieve the stones and gall bladder.

• Brand Name: GENICON 2EZEE SPECIMEN RETRIEVAL BAG
• 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 ; 6574851401
• MDR Report Key: 10359168
• MDR Text Key: 204938882
• Report Number: 3002590791-2020-00050
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0449-B(11)190528(17)201127
• 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: 08/03/2020

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: 11/27/2020
• Device Model Number: 550-000-200
• Device Lot Number: J0449-B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1