VDW GMBH WST 6:1 F. VDW.GOLD/SILVER; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
|
Back to Search Results |
|
Catalog Number V041079000000 |
Device Problems
Detachment of Device or Device Component (2907); Output Problem (3005)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
In this event it is reported that wst 6:1 f.Vdw.Gold/silver contra angle does not hold files.Outcome of this event is unknown as of this mdr.
|
|
Manufacturer Narrative
|
There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
|
|
Manufacturer Narrative
|
Nc073695/gr23554/ca-sn:(b)(6):battery (voltage collapses under load) defective, replaced.Handpiece tray (broken) defective, replaced.Contra angle02934(2006) does not hold the files (collet dirty, plain bearing damage, has an increased electrical resistance value) defective.Repaired.Micromotor gmr1658823 has no error.Foot control, measuring cable set, charger could not be checked because they were not included.The case has broken in several places (probably due to an impact) has no effect on the function.Please fully charge your device before using it for the first time! function test and test measurements without errors s:119.F:81.Numbers of hours of use: 27:30:42.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
|
|
Search Alerts/Recalls
|
|
|