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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC. 10FR FIXEDPIN HEMOSTATIC PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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GYRUS ACMI, INC. 10FR FIXEDPIN HEMOSTATIC PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number CD-B612LA
Device Problems Break (1069); Output Problem (3005); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  Malfunction  
Event Description

Medical device did not function as expected and could not be used on patient - replacement by vendor requested. The tip which delivers the electrical charge to the patient "was not intact," and that the device would not work.

 
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Brand Name10FR FIXEDPIN HEMOSTATIC PROBE
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
GYRUS ACMI, INC.
2400 ringwood ave.
san jose CA 95131
MDR Report Key8869340
MDR Text Key153545532
Report Number8869340
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/16/2019,07/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCD-B612LA
Device LOT NumberMK669752
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2019
Event Location Hospital
Date Report TO Manufacturer08/07/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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