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 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between october 2017 through december 2019.The device was not returned to genicon for evaluation.There were photographs provided for the investigation.

Event Description

Average gall bladder, routine case.Nothing of significance to note about procedure.Should have been an easy extraction of specimen.After minimal effort to extract bagged sample by the senior resident he expressed concern to a second doctor that the bag felt as if it would not hold.The second doctor took over, widened the surgical site and as soon as he began to extract the bag/specimen, the tip burst at very distal tip.Post case discussion, the first doctor said he has been in several cases with the genicon bag and the genicon bag "stretches"- said the other bags don't stretch.He said he has learned from his other cases that this "stretch" can give a false sense of security in that it feels (tactile feedback) as though you are making progress in the extraction but really you are just stretching the bag until it bursts.The second doctor added that other bags (competitor) do not stretch ever.That if they do get a tear or burst it is due to extremely large specimen and surgeon not taking the steps to aspirate, remove large stones separately and to widen the site.This was not one of those cases- said this was a firm stone but average size specimen and the site was widened.(product experience report (b)(4)).

• 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: 10362740
• MDR Text Key: 231724754
• Report Number: 3002590791-2020-00049
• 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: 08/04/2020

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: 08/04/2020
• 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