MAUDE Adverse Event Report: VDW GMBH VDW.SILVER RECIPROC; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number V041163000000

Device Problem Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that a vdw.Silver reciproc having mechanical issue - showing error 2 code.The outcome of this event is unknown as of this mdr.Further information requested.

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.

Manufacturer Narrative

Additional information received: no injury occurred in this event.Investigation results: (b)(6):battery overcharged (charging- cycles started 298x.In relation to the device´s working hours (6:06:11) would be necessary only 3 charging-cycles.) defective, as desired not replaced.Handpiece holder broken, replaced.Contra angle 147421 (2021) (head drive damaged) defective, as desired not repaired.Housing (broken in several places, probably drop.Misuse) defective, as desired not replaced.Charger, micro motor (b)(6), foot control 195896 was deep investigated with the result that no fault has been found.Please note that the device is unchecked and unrepaired, and thus not suitable for use on patients.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Fda coding that was initially reported in the initial report for health effect- clinical code is being corrected from code 4580 to 4582.This is a follow up report to correct this code.Fda coding that was initially reported in the initial report for health effect- impact code is being corrected from code 4648 to 2199.This is a follow up report to correct this code.

• 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 Key: 17779812
• MDR Text Key: 323792526
• Report Number: 9611053-2023-00850
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V041163000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/18/2023
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1