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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDSWITCH; UNIT, OPERATIVE DENTAL
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HANDSWITCH; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100009000
Medical Device Problem Code Device Remains Activated (1525)
Health Effect - Clinical Codes No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/30/2020
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 investigation type has not yet been determined.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 had run-on.1 event had no patient involvement; no patient impact.
 
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.1 previously reported event is included in this follow-up record.Product return status: 1 device was not available for evaluation.H3 other text : device not available.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device had run-on.1 event had no patient involvement; no patient impact.
 
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Brand Name
HANDSWITCH
Common Device Name
UNIT, OPERATIVE DENTAL
MDR Report Key10329666
Report Number0001811755-2020-01835
Device Sequence Number16866312
Product Code EIA
UDI-Device Identifier04546540074393
UDI-Public04546540074393
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,Followup
Report Date (Section B) 07/29/2021
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 Number5100009000
Device Catalogue Number5100009000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/30/2020
Supplement Date Received by Manufacturer06/30/2020
Initial Report FDA Received Date07/27/2020
Supplement Report FDA Received Date07/29/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
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