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

Model Number 500-000-200

Device Problem Material Fragmentation (1261)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaints received between october 2017 and december 2019.A root cause for the broken bag could not be determined.

Event Description

The case was a laparoscopic cholecysectomy.The 550-000-200 specimen bag was successfully deployed and the patient's gallbladder was placed in the bag without issue.The string was released from the handle and bag was cinched closed, followed by the removal of the introducer and trocar, leaving just the bag/specimen in the abdomen.The surgeon was able to fairly easily pull the bag and specimen through and nearly had the entire bag and specimen out when the bag ruptured, leaving the gallbladder half way out.Clamps were placed to try and retrieve the specimen in it's entirety but that caused the gallbladder to rupture as well and only half of it was retrieved.The surgeon reinserted the 10mm trocar through the same defect and that pushed the remaining half the gallbladder and large stones back into visualization from within the abdomen.The surgeon then deployed a second bag to retrieve it and all the remaining stones that had fallen into the abdominal cavity.The bag rupture caused a delay in the procedure, added approximately an additional 20 min to the case time, and required a second bag.

• Brand Name: 2EZEE
• 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
• MDR Report Key: 10250254
• MDR Text Key: 199289481
• Report Number: 3002590791-2020-00033
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)I9845-A(11)180911(17)200310
• 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: 07/08/2020

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: 03/10/2020
• Device Model Number: 500-000-200
• Device Lot Number: I9845-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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