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	06/24/2019
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.The device was not returned for evaluation.Three (3) photos were provided for the investigation.Complaint record (b)(4) initially contained product experience report (b)(4); complaint record (b)(4) was initiated to address per (b)(4) separately, and manufacturer report 3002590791-2020-00049 was filed for (b)(4).
Event or Problem Description
Average gall bladder, routine case.Nothing of significance to note about procedure.Should have been an easy extraction of specimen.Surgeon widened incision to accommodate the bag/specimen as it started to stretch immediately.Surgeon wanted to avoid a break, so he widened the incisino a second time and widened the surgical site with kelly style instrument.After a very short time, and minimal effort to extract bag/specimen the bag ripped from the distal tip up to about 2 inches.See pictures of stretched bag with large torn opening.Surgeon stated firmly that he "wanted these bags out of his or"- he called the crd by the time i arrived at her office to relay the same statement.(surgeon also noted prior to extraction that the bag would not close all the way with the cinch cord which i did observe and also observed 1st hand several times in my in-service demos with several different sample bags).

• Brand Name: GENICON 2EZEE SPECIMEN RETRIEVAL BAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• MDR Report Key: 10362742
• Report Number: 3002590791-2020-00048
• Device Sequence Number: 2329720
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0449-B(11)190528(17)201127
• 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): 08/04/2020

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: 11/27/2020
• Device Model Number: 550-000-200
• Device Lot Number: J0449-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1