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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 Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation. The cause of the reported event cannot be determined. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the device was found not working, the probe failed to work. There was no patient involvement 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 Key11154851
MDR Text Key250463075
Report Number3011050570-2021-00011
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCD-B622LA
Device Lot NumberKR914615
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 Received04/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2020
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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