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

Model Number	550-000-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between october 2017 through december 2019.
Event or Problem Description
Lap chole case with the doctor using the new 550-000-200 bag at the hospital.The customer said several doctors complained about the quality of the original poly bag, and previously had 2 torn bags but they did not note the item or lot numbers.So we converted to the new bags in an attempt to save the account.In the first case while trialing the new genicon bag, the bag tore while trying to remove from patient.The tear was near the bottom of the bag, and the stone fell back into the abdomen.

• Brand Name: GENICON 2EZEE
• Common Device Name: POLY SPECIMEN RETREIVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10387875
• Report Number: 3002590791-2020-00053
• Device Sequence Number: 1865542
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0408-B(11)190510(17)221109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 550-000-200
• Device Lot Number: J0408-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1