MAUDE Adverse Event Report: GENICON, INC. GENISTRONG SPECIMEN RETREIVAL BAG, LARGE; SPECIMEN RETRIEVAL BAG

Model Number 550-000-005

Device Problem Material Rupture (1546)

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

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.The device was returned to genicon for evaluation, however one photograph was provided.

Event Description

Bag broke during robotic lobectomy.See picture.According to information obtained by rep, the bag broke while the specimen was inside the chest cavity and they were trying to pull it out.A 10 inch incision was made on patient's chest to remove specimen.(b)(6).

Manufacturer Narrative

Updated b4 with current date of this report, d2 corrected typographical error in word "retrieval"), g7 (noted follow up and 001), h2 noted "correction" as follow up type, corrected h10 (manufacturer's narrative) to clarify that "the device was not returned to genicon for evaluation.".

• Brand Name: GENISTRONG SPECIMEN RETREIVAL BAG, LARGE
• Type of Device: SPECIMEN RETRIEVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• MDR Report Key: 10362739
• MDR Text Key: 205156130
• Report Number: 3002590791-2020-00063
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972005186
• UDI-Public: (01)00877972005186(10)I9410-J(11)18511(17)210510
• 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: 08/11/2020

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: 05/10/2021
• Device Model Number: 550-000-005
• Device Lot Number: I9410-J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1