MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWERV3 ULTRASONIC SCALER

Model Number UM3-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

The user facility reported that during a dental procedure the insert detached from the swerv3 ultrasonic scaler and lacerated the patient's tooth.

Manufacturer Narrative

The device subject of the event was not returned for evaluation and a lot number was not provided.Without the return of the device, the cause of the reported issue cannot be determined.A follow-up mdr will be submitted should the device be returned for evaluation.

• Brand Name: SWERV3 ULTRASONIC SCALER
• Type of Device: SCALER
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 3232 n rockwell st.; chicago, IL 60618 ; 4403927453
• MDR Report Key: 19073997
• MDR Text Key: 340573744
• Report Number: 1416605-2024-00002
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075859
• UDI-Public: 10889950075859
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/09/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: UM3-30
• Device Catalogue Number: UM3-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1