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

Model Number 550-000-200

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2020

Event Type  malfunction  

Event Description

During a laparoscopic cholecystectomy surgery, the specimen retrieval bag deployed into the patient broke (described as shattered in pieces) at the bottom when the specimen was being removed from the patient.Specimen was said to be of normal size and no excessive tugging was involved.The staff discarded the bag and completed the surgery with a competitor's device.The procedure was extended to make sure pieces of the specimen retrieval bag were all retrieved.There was no report patient harm.

• Brand Name: 2EZEE
• 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: 10113189
• MDR Text Key: 200839795
• Report Number: 3002590791-2020-00067
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: 00877972007289
• 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: 06/02/2020

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: 01/07/2021
• Device Model Number: 550-000-200
• Device Lot Number: J0574-B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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