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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TTBIO CORP HENRY SCHEIN; HANDPIECE
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TTBIO CORP HENRY SCHEIN; HANDPIECE Back to Search Results
Model Number MAXIMA PRO 2L HP MINI HEAD FO
Medical Device Problem Codes Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/13/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Bur attachment falls off from device during treatment; no patient injuries.
 
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Brand Name
HENRY SCHEIN
Common Device Name
HANDPIECE
Manufacturer (Section D)
TTBIO CORP
2f, no. 7, 6th road
industry pa
taichung, 40755
TW  40755
MDR Report Key19530241
Report Number3007007357-2024-00017
Device Sequence Number12682992
Product Code EFB
UDI-Device Identifier00304040090053
UDI-Public(01)00304040090053(01)00304040090053(21)23120368,(01)00304040090053(21)24014724
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/13/2024
Report Date (Section F) 06/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberMAXIMA PRO 2L HP MINI HEAD FO
Device Catalogue Number570-1073
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2024
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/16/2024
Device Age8 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/14/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/13/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
Date Report Sent to FDA06/13/2024
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