MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET PLUS W/TAPON-115V G137(DNA); SCALER, ULTRASONIC

Catalog Number 8187501

Device Problems Restricted Flow rate (1248); Overheating of Device (1437); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

While using a cavitron jet plus g137, they allege that they have no water and the handpiece is heating up, no injury resulted.

Manufacturer Narrative

There has been a previous report received where lack of water flow has caused an overheating insert.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.

Manufacturer Narrative

Investigation results: emh hp; cable, conn/gun cable damaged.The hpc is damaged, restricting water flow, pinched tubing.Water solenoid is damaged, intermittent water flow.Clogged powder bowl, due to moisture, worn overlay board.Damaged air manifold, restricting air flow, powder in duckbill filter.Fc base pad is peeling off, debris in water filter.Check calibrations.Will repair unit upon estimates approval.The jm and aux cable were not sent in for evaluations.

• Brand Name: CAVITRON JET PLUS W/TAPON-115V G137(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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18691323
• MDR Text Key: 335168275
• Report Number: 2424472-2024-00009
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• 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: 03/14/2024

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: 8187501
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/14/2024
• 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