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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL
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COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number SCD396
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a procedure, the tip of the device broke off inside the patient while activating.The material was removed.A new similar device was opened and used to complete the procedure.There was no patient injury.
 
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Brand Name
SONICISION
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer (Section G)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer Contact
lisa hernandez
5920 longbow drive
boulder, CO 80301
2034925563
MDR Report Key8724865
MDR Text Key148946844
Report Number1717344-2019-00804
Device Sequence Number1
Product Code LFL
UDI-Device Identifier20884521052663
UDI-Public20884521052663
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCD396
Device Catalogue NumberSCD396
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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