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U.S. Department of Health and Human Services

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

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GENICON, INC. GENICON 2EZEE POLY SPECIMEN RETRIEVAL BAG Back to Search Results
Model Number 550-000-200
Device Problem Material Integrity Problem (2978)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/29/2020
Event Type  Malfunction  
Event Description

The event occurred during the surgeon's third case on (b)(6) 2020. The case involved a gallbladder with a large stone. By his own admission, the surgeon stated he worked the bag vigorously in the same fashion he would have with the competitive product, applied bag. He did witness the bag stretch. Subsequently, he did extend the fascia incision. Upon further tugging after extending the fascia, the bag burst along the bottom. Per follow-up from the distributor's representative, the specimen filled up approximately 50% of the bag. There was no harm to the patient due to delay/break.

 
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Brand NameGENICON 2EZEE
Type of DevicePOLY SPECIMEN RETRIEVAL BAG
Manufacturer (Section D)
GENICON, INC.
6869 stapoint ct.
suite 114
winter park, fl
Manufacturer (Section G)
GENICON, INC.
6869 stapoint ct.
suite 114
winter park, fl
Manufacturer Contact
marianne feyas
6869 stapoint ct
suite 114
winter park, fl 
6574851
MDR Report Key9925663
MDR Text Key202554259
Report Number3002590791-2020-00010
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK180836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Type of Report Initial
Report Date 04/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number550-000-200
Device LOT NumberJ0634-B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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