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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR FIXEDPIN HEMOSTATIC PROBE

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GYRUS ACMI, INC 7FR FIXEDPIN HEMOSTATIC PROBE Back to Search Results
Model Number CD-B622LA
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation. The cause of the issue cannot be determined at this time. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that during a therapeutic hemostasis procedure the bicoagulation probe unit was found not able to conduct electricity. The user changed with another probe and the intended procedure was completed. There was no patient harm or impact was reported. No user injury reported.
 
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Brand Name7FR FIXEDPIN HEMOSTATIC PROBE
Type of Device7FR FIXEDPIN HEMOSTATIC PROBE
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
Manufacturer Contact
kenneth pittman
9600 louisiana avenue north
brooklyn park, MA 55445
9013785969
MDR Report Key10887477
MDR Text Key219550280
Report Number3011050570-2020-00154
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K123319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCD-B622LA
Device Lot NumberKR914613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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