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

Model Number 550-000-003

Device Problem Material Rupture (1546)

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Filed for genicon complaint record (b)(4).

Event Description

Surgeon has been using the genicon net for his lap chole's and he says the nets keep breaking.We had another surgeon experience similar problems.When the nets break, it poses a threat to our patient's safety because another net needs to be opened and the broken net needs to be retrieved from the patient's abdomen.This is the third report for our facility concerning the same product, refer to prior medsun reports (b)(4).

• Brand Name: GENICON GENISTRONG SPECIMEN RETRIEVAL BAG, MEDIUM
• 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: 10411422
• MDR Text Key: 204379916
• Report Number: 3002590791-2020-00102
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007036
• UDI-Public: (01)00877972007036(10)J0833-A(11)191121(17)221120
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 550-000-003
• Device Lot Number: J0833-A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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