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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VDW GMBH VDW.SILVER RECIPROC; CONTROLLER, FOOT, HANDPIECE AND CORD
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VDW GMBH VDW.SILVER RECIPROC; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number V041163000000
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, calibration related issues in endo motors have led to file separation in the past.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Battery (voltage breaks down under load) defective, contra-angle handpiece and foot control were not included.Micromotor smr1560267 is not defective.
 
Event Description
In this event it was reported that a vdw.Silver reciproc stops during treatment.No injury occurred.
 
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Brand Name
VDW.SILVER RECIPROC
Type of Device
CONTROLLER, FOOT, HANDPIECE AND CORD
Manufacturer (Section D)
VDW GMBH
bayerwaldstrasse 15
munich bayern 81737
GM  81737
Manufacturer (Section G)
VDW GMBH
bayerwaldstrasse 15
munich bayern 81737
GM   81737
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key13002437
MDR Text Key282218039
Report Number9611053-2021-00438
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/22/2021
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
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