MAUDE Adverse Event Report: VDW GMBH VDW.GOLD RECIPROC; LOCATOR, ROOT APEX

Catalog Number	V041173000000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Insufficient Information (4580); 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.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 or Problem Description
In this event it was reported that the apex locator of a vdw.Gold reciproc does not work ( no sound/no visual sign ) when it comes to the apex length.Outcome of patient injury is pending.
Additional Manufacturer Narrative
Additional information received: no injury occurred.Investigation results: investigation and repair done by ds maillefer/siroforce ticket no.8001357617: file clip cable and lip clip cable defect and replaced.Motor holder broken.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code : 4580, health effect - impact code : 4648, the correct codes for this complaint are: health effect - clinical code : 4582, health effect - impact code : 2199, this is a follow up report to correct this code.

• Brand Name: VDW.GOLD RECIPROC
• Common Device Name: LOCATOR, ROOT APEX
• 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: 23857838
• Report Number: 9611053-2025-00180
• Device Sequence Number: 20091163
• Product Code: LQY
• UDI-Device Identifier: E27667790160
• UDI-Public: E27667790160
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/03/2026

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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown