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 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.Refer to complaint file (b)(4).

Event Description

The bag broke inside of the patient.The surgeon had to spend 30 minutes retrieving the specimen from patient.The surgical techs also said that 3-4 bags had broken the week before in the trocar.Upon investigation with the staff, the bags have broken 3-4 other times over the course of a couple of weeks.These bags did not break inside the patient, however they did break during bag removal through the defect after the trocar was removed.All bag breaks were at the bottom of the bag.It was stated that "it wasn't so much of a tear, but the bag popped.".

Manufacturer Narrative

Correction report: for fields b4, h3, h5, and h8.

• 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
• MDR Report Key: 10359170
• MDR Text Key: 204937952
• Report Number: 3002590791-2020-00047
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K180836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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 Model Number: 550-000-200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1