MAUDE Adverse Event Report: VDW GMBH VDW.GOLD RECIPROC; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number	V041173000000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.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.
Event or Problem Description
In this event it is reported that vdw.Gold reciproc giving incorrect measurements with the apex locator.Customer having problem with the apex locator, even after changing mouth wire.Error still reads.No injury reported.
Additional Manufacturer Narrative
Siroforce ticket no.(b)(4) defective battery.H:16:29:12 s:219 f:156.Defective charger.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: VDW.GOLD RECIPROC
• Common Device Name: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23854329
• Report Number: 9611053-2025-00178
• Device Sequence Number: 16046017
• Product Code: EGS
• UDI-Device Identifier: E27667790160
• UDI-Public: E27667790160
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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
• Device Catalogue Number: V041173000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown