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

Model Number 550-000-200

Device Problems Material Fragmentation (1261); Human-Device Interface Problem (2949)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

Genicon has completed a thorough review of all available records related to this device and associated lot numbers.Records indicate that this lot passed all manufacturing and quality control inspections.All raw materials used passed incoming quality control checks and no irregularities or abnormalities were found.Genicon has validated and strictly controls the manufacturing process used to form the bag.This process is routinely monitored through the use of destructive peel tests on samples pulled directly off the manufacturing line at designated intervals.This specific product is tested at three (3) locations along the edge of the bag, and all tested samples for these lots met the pre-determined minimum requirements at the time of the testing.Additionally this data is statistically trended and analyzed for non-obvious patterns or potential flaws, of which none were found.Review of vigilance reports did not reveal any trends, with respect to an increase in frequency, or a trend to a specific lot.Unfortunately the suspect devices were not able to be retained for evaluation and no pictures were provided for review.In the absence of the suspect devices and given the available information, the failure could not be confirmed and the exact root cause of this event could not be determined.Although the root cause remains unknown, it is important to note that the bag can tear if contact is made with a sharp instrument (i.E.Scissors, clips, etc.), or if the bag is pulled with extreme force through a port site too small for the bag with the specimen inside.Care should be taken to follow all warnings, precautions and directions detailed in the instructions for use to ensure the highest level of safety and patient care.The ifu states, "care should be taken to avoid contact of the bag with sharp instruments, cutting devices, and electrosurgical and laser instrument," and, "excessive forces should be avoided during bag extraction to avoid any bag stretching or tearing.If the bag and its contents are too large to be extracted, carefully enlarge the access site to facilitate easy bag removal." the narrative indicates that bag material fragmented, and had to be retrieved from the patient which did not result in patient harm in this instance, but has a potential for material be to be left behind.Therefore, out of an abundance of caution, genicon is notifying the appropriate regulatory authorities.Genicon will continue to monitor this issue through our vigilance system for trends, and take appropriate actions as necessary to ensure the continued performance and safety of the product.

Event Description

Initial report from customer: "the bag ruptured and left pieces of the bag inside the patient's abdomen.Plus an additional 4 other ruptures.Surgeons refuse to use anymore." follow-up report: "when attempting to utilize the bags, the bags tore upon removal through the defect.Tears were at the bottom of the bag on 3 of the bags.A new bag was used each time.A different bag tore apart into multiple pieces.As a result the scrub tech had to piece the bag back together on the back table to ensure all the pieces were removed from the patient's abdomen.Facility cannot locate bags for return.".

• 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: daniel doerr ; 6869 stapoint court; suite 114; winter park, FL 32792 ; 4076574851
• MDR Report Key: 8903478
• MDR Text Key: 216647073
• Report Number: 3002590791-2019-00007
• 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
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: 550-000-200
• Device Catalogue Number: 550-000-200
• Device Lot Number: J0468-B AND J0452-B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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