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

Catalog Number	USG1030KSP
Medical Device Problem Codes	Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Scaler tip broke in patients mouth during procedure.
Additional 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.Bgb.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".Risk assessment: probability: remote.Severity: minor.Risk: minimal.Capa required: no (isolated incident to one customer).
Additional Manufacturer Narrative
The tip has broken off almost half way up the insert tip.This could be due to customer abuse of due to a defect during manufacturing, or due to a defect in material from the parts supplier.(b)(4).Low power unit readings: low power setting: 8.6 w; 29,047hz.High power setting: 31.0w; 29,082hz.High power unit readings: low power setting: 18.1w; 29,099hz.High power setting: 30.2w; 29,105hz.Solder joint: 1/8".Spray: good.The part was manufactured in april 2017.There is one additional complaint of a tip breaking for this part number between april 2017 and april 2018.Risk assessment: probability: remote.Severity: minor.Risk: minimal.Capa required: no (isolated incident to one customer).

• Brand Name: BIOSONIC
• Common Device Name: ULTRASONIC SCALER TIP
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808475
• Report Number: 2416455-2018-08232
• Device Sequence Number: 16752688
• Product Code: ELC
• UDI-Device Identifier: D661USG1030KSP0
• UDI-Public: D661USG1030KSP0
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K983727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: USG1030KSP
• Device Lot Number: 2017/04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018; 04/12/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/10/2018; 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1