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

Model Number 550-000-200

Device Problem Human-Device Interface Problem (2949)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

No product nor pictures were provided.The only known way to cause this failure is to cinch the bag with the arms still attached.That is against instructions for use.User error was the confirmed root cause.There is no change to design or production.No corrective action required.Ifu appropriately lists steps for use.

Event Description

(b)(4).Initial report: dr (b)(6) deployed the bag to retrieve a specimen and the arms of the device reportedly went through the bag and lacerated the liver.This information is from the operating room director as the surgeon and the staff that were in the room at the time are unavailable during this reporting.From rep meeting on (b)(6) 2019 to gather additional details,: dr (b)(6) was a new user to the bag.I in-serviced and did case support (one case) prior to the event.His first assist, (b)(6), usually deploys the bag in the robotics cases; this was a right robotic-assisted laparoscopic partial nephrectomy.Operative report states the following: complications: deployment of the retrieval bag, prong lacerated the posterior liver 1 to 2 cm.Description of procedure: [?]."i then sharply excised the tumor and placed it in a retrieval bag, which at that point, the right prong when opened, then created a small posterior laceration to the liver, had a very small ooze.We proceeded to pay attention to the kidney , which was oozing more so than the liver.I placed the bag off to the side".[?]."in the meantime, i had placed floseal and surgicel over the liver.This was subsequently removed and evaluated.No active bleeding.I did place tisseel over it to assure no further bleeding as well as the right kidney." incident report filed by (b)(6), rn.The device is not available.

• Brand Name: 2EZEE
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer (Section G): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer Contact: katlyn kachman ; 6869 stapoint court; suite 114; winter park, FL 32792 ; 4076574851
• MDR Report Key: 8831644
• MDR Text Key: 152452835
• Report Number: 3002590791-2019-00006
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 550-000-200
• Device Catalogue Number: 550-000-200
• Device Lot Number: J0408-B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention