Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE; INSTRUMENT, ULTRASONIC SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number 5450850000
Medical Device Problem Code Inability to Irrigate (1337)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/30/2021
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: 5 events were reported for this quarter.Product return status 5 devices were received.Additional information: 5 devices were not labeled for single-use.5 devices were not reprocessed or reused.
 
Event or Problem Description
This report summarizes 5 malfunction events in which the device experienced an irrigation issue that could lead to overheating.2 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12204175
Report Number0008043928-2021-00016
Device Sequence Number4486496
Product Code LFL
UDI-Device Identifier07613327291872
UDI-Public07613327291872
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized5
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/21/2021
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 Number5450850000
Device Catalogue Number5450850000
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/30/2021
Initial Report FDA Received Date07/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-