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

Catalog Number V041163000000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it was reported that vdw silver reciproc stopped during treatment.At this time unknown if any injury to patient; a request regarding any injury has been sent.

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.After inspection of device it was found to have battery defective (was charged 116 times with an operating time of 57.54.55 hours, 29 charging cycles would have been sufficient).Micromotor smr 115074 (we discovered residues of liquids or oil while checking your motor) defective.Motor holder (broken) defective.Foot control 32735 (broken cable) is defective.The housing has cracked (possibly due to a shock) and has an effect on the function (defective).When the housing is renewed, the display screen and the membrane keyboard must also be replaced.Sent in without contra-angle handpiece and power supply.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

• 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: 13171516
• MDR Text Key: 284370354
• Report Number: 9611053-2022-00446
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• 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: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2021
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1