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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 Problems Mechanical Problem (1384); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that a vdw.Silver reciproc stops during treatment; no injury resulted.
 
Manufacturer Narrative
After a long-term test, no reduced battery performance could be determined.Foot control (b)(6), micromotor (b)(6) and contra-angle handpiece (b)(6)(2012) are not defective.
 
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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 Key12213387
MDR Text Key265148772
Report Number9611053-2021-00241
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 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
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? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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