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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW SILVER RECIPROCATING MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD
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DENTSPLY VDW GMBH VDW SILVER RECIPROCATING MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number V041163000000
Device Problem Retraction Problem (1536)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4).Battery (breaks under load together) defective, replaced.Foot control (b)(4) (insulation cracked) defective, replaced with (b)(4) micro motor smr (b)(4) and contra-angle (b)(4) without error.Function test and test measurements without error.Battery was completely charged.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
 
Event Description
In this event it was reported that a silver reciprocal motor suddenly stops during use.The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Additional information was received indicating that no injury resulted.
 
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Brand Name
VDW SILVER RECIPROCATING MOTOR
Type of Device
CONTROLLER, FOOT, HANDPIECE AND CORD
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
MDR Report Key9073557
MDR Text Key160066911
Report Number9611053-2019-00315
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041163000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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