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U.S. Department of Health and Human Services

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

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GYRUS ACMI, INC 7FR COAX HEMOSTATIC PROBE Back to Search Results
Model Number CD-B620LA
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 07/27/2020
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 the device was found with broken tip. The issue occurred when the user was opening the package. There was no patient involvement on this report. No user harm or injury was reported.
 
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Brand Name7FR COAX HEMOSTATIC PROBE
Type of Device7FR COAX 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 Key10431101
MDR Text Key203669864
Report Number3011050570-2020-00048
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCD-B620LA
Device Lot NumberKR912059
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2003
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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