• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-SLI-1000 INSERT,PKD; SCALER, ULTRASONIC

  • 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
 

DENTSPLY LLC 30K FSI-SLI-1000 INSERT,PKD; SCALER, ULTRASONIC Back to Search Results
Catalog Number 81570
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Since an overheating insert 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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it is reported that a 30k fsi-sli-1000 insert,pkd, alleged that the insert got hot.No injury reported.
 
Manufacturer Narrative
Returned qty.(b)4) inserts, 1.81570, 3238, 25, bul test method / (b)(4) inductance: gauge id# (b)(4) due: 11/30/2024 result: 2.47 meets spec does not meet spec n/a tip condition: - meets spec does not meet spec n/a stack condition meets spec does not meet spec n/a tested on: g136 gage id# (b)(4) due date: 03/31/2023 set pressure: 35 psi water flow: output rate: (b)(4) - meets spec does not meet spec n/a spray pattern: - meets spec does not meet spec n/a water leak: hp sealing ring proximal ring distal ring seam leak n/a vibration: - meets spec does not meet spec n/a grip condition: meets spec does not meet spec n/a other visual observation: insert laminate stack is bent.Insert was tested on a digital thermometer i.D.(b)(4) due date: 09/30/2023 and the temperature was 84.9°f is good.The specification states are not to exceed 118.4°f (per frs-9175).Alleged event: confirmed - not confirmed 2.81570, 5196, 39, bul test method / (b)(4) inductance: gauge id# (b)(4) due: 11/30/2024 result: 3.09 meets spec does not meet spec n/a tip condition: - meets spec does not meet spec n/a stack condition meets spec does not meet spec n/a tested on: g136 gage id# (b)(4) due date: 03/31/2023 set pressure: 35 psi.Water flow: output rate: (b)4) - meets spec does not meet spec n/a.Spray pattern: - meets spec does not meet spec n/a.Water leak: hp sealing ring proximal ring distal ring seam leak n/a vibration: - meets spec does not meet spec n/a grip condition: meets spec does not meet spec n/a other visual observation: insert has hp sealing o-ring water leak.Insert was tested on a digital thermometer i.D.# (b)(4) due date: 09/30/2023 and the temperature was 79.1°f is good.The specification states are not to exceed 118.4°f (per frs-9175).Alleged event: confirmed - not confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
30K FSI-SLI-1000 INSERT,PKD
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
DENTSPLY LLC
1301 smile way
york PA 17404
Manufacturer (Section G)
DENTSPLY LLC
1301 smile way
york PA 17404
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key16213780
MDR Text Key308379586
Report Number2424472-2023-00342
Device Sequence Number1
Product Code ELC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K052334/K970
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number81570
Device Lot Number3238 & 5196
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date01/17/2023
Date Manufacturer Received01/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage A
Patient Sequence Number1
-
-