MAUDE Adverse Event Report: DENTSPLY LLC CAV. PLUS TAP-ON G136; SCALER, ULTRASONIC

Catalog Number G136

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

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

Event Type  malfunction  

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.After inspection of device found that corrosion on hp cable contacts causing intermittent operation, no oscillation due to an open condition in the steri-mate handpiece; causing no water flow leading to hp over heating.Replaced damaged/worn components and recalibrated unit to factory specs.Dhr review is not required because the product was returned for evaluation and the customer issue is a known hazard.

Event Description

Based on the repair evaluation of the g136 scaler there was corrosion on handpiece cable contacts causing intermittent operation, no oscillation due to an open condition in the steri-mate handpiece; causing no water flow leading to the handpiece over heating.No injury resulted.

• Brand Name: CAV. PLUS TAP-ON G136
• 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: 12719277
• MDR Text Key: 279027778
• Report Number: 2424472-2021-00075
• 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
• Report Date: 10/28/2021

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: G136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1