MAUDE Adverse Event Report: COLTENE WHALEDENT INC. BIOSONIC; ULTRASONIC SCALER TIP

Model Number US1030KOS

Device Problems Break (1069); Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

Scaler tip broke during procedure.

Manufacturer Narrative

The tip of the inset has broken off, this may be due to a manufacturing defect during manufacturing, or it could be a defect in the material from an outside supplier.There is also the possibility of customer abuse, the insert may have been used as a pick to remove material.(b)(4).Low power unit: low power setting: 8.4w, 29,009hz.High power setting 31.4w, 29,025hz.High power unit: low power setting: 17.7w, 29,078hz.High power setting: 31.7w, 29,073hz.Spray, good at how power only.Solder joint, 3/16".Task for (b)(4): quality department: status: task completed; follow-up action completed.Review complaint.06/23/2018 21:03:41 cet (b)(4), risk is negligible, no capa required.Risk/capa assessment: 09/07/2018 15:52:48 cet (b)(4) complaint history was reviewed in sap.The part was manufactured in january 2018.This complaint is the only instance of a tip breaking for this part number between january 2017 and january 2018.Risk assessment: probability: remote.Severity: minor.Risk: minimal.Capa required: no (isolated incident to one customer).

• Brand Name: BIOSONIC
• Type of Device: ULTRASONIC SCALER TIP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808551
• MDR Text Key: 118242193
• Report Number: 2416455-2018-08234
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D661US1030KOS0
• UDI-Public: D661US1030KOS0
• Combination Product (y/n): N
• PMA/PMN Number: K983727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US1030KOS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1