MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR (DNA); SCALER, ULTRASONIC

Catalog Number G310SCLR

Device Problem Overheating of Device (1437)

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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

While the customer was using a cavitron 300 series g310 they allege that the handpiece and insert tips are overheating.No injury was reported from the alleged event.

Manufacturer Narrative

Within warranty? no.Notes: "(b)(6) 2024 repair tech: (b)(6).Emv hp; cable, conn/gun cable open.Wrench #1 is illuminated - no operation due to an open condition in the handpiece cable.As customer's complaining, hp is properly damaged.Added hp in the repair.Updated latest version of software to improve performance and fixed all issues.Hardened and deteriorated water supply hose, debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Qa - ds.No handpiece received for evaluation." for proper evaluation please always send in all accessories that go along with the unit handpiece # (b)(6).Handpiece cable # old (b)(6)-- new (b)(6).

• Brand Name: CAVITRON 300 SERIES G310SCLR (DNA)
• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 19097580
• MDR Text Key: 340122214
• Report Number: 2424472-2024-00028
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00382703121
• UDI-Public: D00382703121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G310SCLR
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1