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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC. SCALPEL, ULTRASONIC, REPROCESSED

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STERILMED, INC. SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Device Problems Pad (900); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2020
Event Type  Malfunction  
Event Description

The surgical team noticed white pad on the jaw of harmonic scalpel becoming dislodged on the video monitor. Instrument was taken out of the patient's abdomen and the white pad, then the white pad came off the device at that time outside the patient. A new device was opened, case resumed and finished.

 
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Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STERILMED, INC.
5010 cheshire pkwy n ste 2
plymouth MN 55446
MDR Report Key9719888
MDR Text Key179743842
Report Number9719888
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2020
Event Location Hospital
Date Report TO Manufacturer02/18/2020
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?
Type of Device Usage

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