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

Catalog Number UNKNOWN

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

In this event it is reported that unk vdw - vdw.Silver reciproc speed of device is not constant and unstable.The device cannot rotate normally like it is to.

Manufacturer Narrative

There has been a previous report received where stalling 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.Investigation reports that the end of the motor socket is broken, and the motor cable socket needs to be replaced.Root cause the main reason is the wear and tear of equipment.

• Brand Name: UNK VDW 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: 18151862
• MDR Text Key: 328312230
• Report Number: 9611053-2023-00877
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/10/2023
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• Type of Device Usage: A
• Patient Sequence Number: 1