MAUDE Adverse Event Report: DENTSPLY VDW GMBH VDW SILVER RECIPROCATING MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number V041163000000

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.Battery (was charged at an operating time of 08:28:00 hours, 142 x, whereby 2 charging cycles would have been sufficient) defective, replaced on goodwill.Micro motor smr1769084, contra angle 111038 (2017) and foot control 150133 without error.Battery was completely charged.Function test and test measurements without errors.

Event Description

In this event it was reported that a silver reciproc motor suddenly stops during use; no injury resulted.

• 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
• Manufacturer (Section G): ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.; via san donato 1; pistoia, 51100 ; IT 51100
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8947174
• MDR Text Key: 157356141
• Report Number: 9611053-2019-00285
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041163000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1