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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY; ULTRASONIC SURGICAL INSTRUMENT
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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY; ULTRASONIC SURGICAL INSTRUMENT Back to Search Results
Lot Number 3743727
Device Problems Device Alarm System (1012); Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 11/09/2015
Event Type  malfunction  
Event Description
After opening, connecting, and testing a stryker reprocessed harmonic ace shears, upon the first use the harmonic power source said "relax pressure on blade" and "tighten instrument." after the device was retested, the same messages appeared; the device was retested again.Soon after, the device stopped working completely.A new stryker reprocessed harmonic ace shears was opened and connected, with no further problems.This facility has had multiple recent similar events with this device.The manufacturer has been notified.Product has been returned.Staff using the device have received education from the manufacturer's rep regarding the use of the device.The manufacturer has exchanged one entire lot for the same product of a different lot.The problem continues.
 
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Brand Name
HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
Type of Device
ULTRASONIC SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5300region ct
lakeland FL 33815
MDR Report Key5245535
MDR Text Key31982087
Report Number5245535
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Expiration Date06/19/2016
Device Lot Number3743727
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2015
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer11/13/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2015
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age38 YR
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