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

Model Number	550-000-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.
Event or Problem Description
Doctor did a case on friday (b)(6) 2019 and the genicon retrieval bag he used broke while retrieving the specimen.Ref# (b)(4) lot# 19855-a exp.Date 3/16/20.Additional data regarding the same case: on (b)(6), doctor was completing a robotic lap ventral hernia repair.He deployed a 2ezee retrieval bag to remove excess fatty tissue.While removing the bag from the abdomen the tip of the bag tore, spilling the majority of the content into the cavity.At this point, the bag was easily removed and remaining tissue was removed via the trocar.

• Brand Name: GENICON 2EZEE SPECIMEN RETRIEVAL BAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10382944
• Report Number: 3002590791-2020-00042
• Device Sequence Number: 16613108
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)I9855-A(11)180917(17)200316
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2020
• Device Model Number: 550-000-200
• Device Lot Number: I9855-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1