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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
Model Number 5450820000
Medical Device Problem Code Inability to Irrigate (1337)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
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.Additional information: 1 device was 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 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
JA  206-0802
MDR Report Key11729193
Report Number0008043928-2021-00008
Device Sequence Number19806874
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) 04/26/2021
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 Model Number5450820000
Device Catalogue Number5450820000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/01/2021
Initial Report FDA Received Date04/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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