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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONOPET IQ IRRIGATION SUCTION CASSETTE; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO SONOPET IQ IRRIGATION SUCTION CASSETTE; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5500573000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure for an acoustic neuroma the irrigation cassette was leaking.The account reported detecting an electrical burning smell and then the console stopped working.The procedure was completed successfully following a brief delay to retrieve back-up equipment.No medical intervention or adverse consequences were reported.
 
Event Description
It was reported that during a procedure for an acoustic neuroma the irrigation cassette was leaking.The account reported detecting an electrical burning smell and then the console stopped working.The procedure was completed successfully following a brief delay to retrieve back-up equipment.No medical intervention or adverse consequences were reported.
 
Manufacturer Narrative
Additional information: d10, h4.
 
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Brand Name
SONOPET IQ IRRIGATION SUCTION CASSETTE
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9603210
MDR Text Key176808262
Report Number0001811755-2020-00092
Device Sequence Number1
Product Code LFL
UDI-Device Identifier37613327298636
UDI-Public37613327298636
Combination Product (y/n)N
PMA/PMN Number
K190070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5500573000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5500050000,SONOPET IQ CONSOLE,SN (B)(6); 5500255000,SONOPET IQ HANDPIECE,SN (B)(6)
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