Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC ASEPTICO TORQUE MOTOR; HANDPIECE, DIRECT DRIVE, AC-POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TULSA DENTAL PRODUCTS LLC ASEPTICO TORQUE MOTOR; HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number AEU-20
Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received 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 has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
It was reported that an aseptico torque motor was improperly auto-reversing during use; no injury resulted.
 
Manufacturer Narrative
Evaluation found the cable and bearings were damaged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ASEPTICO TORQUE MOTOR
Type of Device
HANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key7597770
MDR Text Key111689155
Report Number2320721-2018-00055
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
PMA/PMN Number
K111078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAEU-20
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-