MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON JET SPS ULTRASONIC SCALER

Catalog Number G120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tinnitus (2103)

Event Date 12/15/2010

Event Type  Injury  

Event Description

In this event a patient alleged that on (b)(6) 2010, shortly after a cavitron unit was turned on and inserted into his mouth that he complained to a hygienist that the unit was "extremely loud" and was causing pain.The same day, the patient claimed to have experienced a persistent ringing in his ears.Around (b)(6) 2010, the patient was diagnosed with tinnitus from acoustic trauma.

Manufacturer Narrative

Because evaluation of the unit involved is not possible and since this issue could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the device malfunctioned and that the 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 was not returned for evaluation and the serial number was not provided for a dhr review.

• Brand Name: CAVITRON JET SPS ULTRASONIC SCALER
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; york PA
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st. ste. 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 3672140
• MDR Text Key: 4345104
• Report Number: 2424472-2014-00001
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K970342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/20/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability