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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 02/13/2018
Event Type  Malfunction  
Manufacturer Narrative

This reportable event was identified during a review of complaint files received between (b)(6) 2017 and (b)(6) 2019. No physical or visual evaluation could be performed; complainant did not take photographs and did not keep the sample for return. A root cause could not be determined.

 
Event Description

The rip-stop nylon strip containing cinching string came detached from the specimen retrieval bag and point of connection to the bag. The specimen retrieval bag fell into patient's abdomen and was retrieved by the surgeon using a grasper.

 
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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 Key10243044
MDR Text Key200838529
Report Number3002590791-2020-00028
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 Date10/10/2020
Device MODEL Number550-000-003
Device LOT NumberI9074
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/11/2017
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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