MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-27 for VDW SILVER RECIPROCATING MOTOR V041163000000 manufactured by Dentsply Vdw Gmbh.
[181635760]
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 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 (b)(4). Battery (voltage breaks down under load) defective, replaced. Micromotor (bent shaft) defective, replaced. Sent in without foot control and power supply. Function test and test measurements without errors. Test carried out according to (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181635761]
In this event it was reported that a silver reciproc motor turns unbalanced and sometimes completely stops. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2020-00041 |
| MDR Report Key | 9764281 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494424 |
| Manufacturer G1 | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
| Manufacturer Street | VIA SAN DONATO 1 |
| Manufacturer City | PISTOIA, 51100 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 51100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VDW SILVER RECIPROCATING MOTOR |
| Generic Name | CONTROLLER, FOOT, HANDPIECE AND CORD |
| Product Code | EBW |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-20 |
| Model Number | NA |
| Catalog Number | V041163000000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |