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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 Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The subject device was not received for evaluation. The user facility conveyed that they did not have the unit to return. No further details were provided. If additional information becomes available this report will be supplemented accordingly. This mdr is being submitted retrospectively as part of a remediation effort related to the recent system, and process changes. A capa has been opened to manage the actions related to remediation of this issue, and any required reporting.
 
Event Description
It was reported that the device did not heat up. The reported issue occurred when the unit was used with bi-coagulation setting. The event occurred during set up, and preparation for use. The user facility biomedical engineer confirmed that the other probes are functional, and with no issues. There was no patient involvement on this report. No user harm 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 Key10723110
MDR Text Key213063561
Report Number3011050570-2020-00121
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 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCD-B620LA
Device Lot NumberUNKNOWN
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 Received11/19/2020
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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