MAUDE Adverse Event Report: GENICON, INC. GENICON 2EZEE RETRIEVAL BAG; 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	07/31/2019
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 had the poly bag out of the trocar site halfway.He then proceeded to put a clamp horizontal across the bag and clamped it about half way and all the way across.He then used the clamp as a t-handle and pulled on it as leverage.The bag started to stretch and right before the gall bladder came out the bag broke in half.The gall bladder however was stuck where doctor could reach into the trocar site and grap it with some pickups.

• Brand Name: GENICON 2EZEE RETRIEVAL BAG
• Common Device Name: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10385373
• Report Number: 3002590791-2020-00055
• Device Sequence Number: 19263749
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0468-B(11)190605(17)201204
• 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): 08/10/2020

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: 12/04/2020
• Device Model Number: 550-000-200
• Device Lot Number: J0468-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1