• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENICON, INC. GENISTRONG SPECIMEN RETRIEVAL BAG Back to Search Results
Model Number 550-000-005
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2018
Event Type  Malfunction  
Manufacturer Narrative

This reportable event was identified during a review of complaints received between (b)(6) 2017 and (b)(6) 2019. A root cause of the broken bag could not be determined from the review of production records and without the actual device to examine.

 
Event Description

Specimen retrieval bag broke while removing specimen from the patient during a lobectomy.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10253562
MDR Text Key200838763
Report Number3002590791-2020-00035
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 07/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date11/09/2020
Device MODEL Number550-000-005
Device LOT NumberI8838
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/10/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-