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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 No Device Output (1435)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
The reference device will not be returned to the service center for evaluation as it was discarded after the procedure. The cause of the reported event cannot be determined. The instruction manual states in the "coagulation" section "if output cannot be activated when the instrument is combined with the electrosurgical generator, inspect the electrosurgical generator as described in its instruction manual. Switch the electrosurgical generator on. Press the foot switch to activate output and perform the coagulation. Cauterize the target tissue. Switch the electrosurgical generator off. Remove the plug from the electrosurgical generator¿s plug connector. ".
 
Event Description
The service center was informed that during an unspecified procedure, when activated to treat the patient¿s bleeding the probe would not generator output. The probe was attached to the competitor¿s generator when activation was attempted. The patient¿s bleeding was treated with a different probe and the intended procedure was completed.
 
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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
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key9311782
MDR Text Key178594258
Report Number2951238-2019-01184
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/25/2019
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

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
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