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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE+ SCALPEL, ULTRASONIC, REPROCESSED

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STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE+ SCALPEL, ULTRASONIC, REPROCESSED Back to Search Results
Catalog Number HAR36
Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/27/2015
Event Type  Malfunction  
Event Description

While using recycled a harmonic scalpel from stryker sustainability solutions (ref# (b)(4)), the plastic jaw piece, approximately 1 cm in length, dislodged from jaw of device, apparently was lost intra abdominally.

 
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Brand NameHARMONIC ACE+
Type of DeviceSCALPEL, ULTRASONIC, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS
1810 west drake drive
tempe AZ 85283
MDR Report Key5017591
MDR Text Key23536663
Report Number5017591
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device Catalogue NumberHAR36
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2015
Event Location Hospital
Date Report TO Manufacturer07/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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