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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDTECH SONOPET ANGLED HANDPIECE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER MEDTECH SONOPET ANGLED HANDPIECE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5450820000
Medical Device Problem Code Inability to Irrigate (1337)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/30/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.  product return status : 1 device was received.Event confirmation status: 1 reported event was not confirmed.Evaluation results: 1 device was found to be affected by a loose angle nut.  additional information: 1 device is not labeled for single-use.1 device was not reprocessed or reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device experienced an irrigation issue that could lead to overheating.1 event had no patient involvement; no patient impact.
 
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Brand Name
SONOPET ANGLED HANDPIECE, UNIVERSAL
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER MEDTECH
1131-1 higashi naganuma
inagi 206-0 802
MDR Report Key9245380
Report Number0008043928-2019-00016
Device Sequence Number11368570
Product Code LFL
UDI-Device Identifier07613327291919
UDI-Public07613327291919
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number5450820000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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