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U.S. Department of Health and Human Services

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

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GENICON, INC. GENISTRONG SPECIMEN RETRIEVAL BAG Back to Search Results
Model Number 550-000-003
Device Problem Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 03/15/2018
Event Type  Malfunction  
Manufacturer Narrative

This reportable incident was identified during a review of complaints received between october 2017 and december 2019. No sample was provided for evaluation. Without a physical evaluation of the device, it is not possible to determine the origination point of the bag break or the root cause of the bag break.

 
Event Description

During a lap cholectomy, the genicon specimen bag was used through a 12mm lap port. The gallbladder was collected with the bag. The correct technique was used to close the bag. The port was pulled out of the patient. The genicon bag was being pulled out of the patient by the string when it was torn in half. The gallbladder had several small and large stones in it which then were scattered back into the abdomen of the patient and throughout the layers of tissue of the abdominal wall. A picture of the broken device inside the abdomen is available.

 
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Brand NameGENISTRONG
Type of DeviceSPECIMEN 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 
MDR Report Key10243042
MDR Text Key199889833
Report Number3002590791-2020-20029
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 07/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/10/2020
Device MODEL Number550-000-003
Device LOT NumberI8828
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/11/2017
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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