MAUDE Adverse Event Report: PARKELL, INC PARKELL; SCALER, ULTRASONIC

Model Number	DURA30-US
Medical Device Problem Codes	Material Fragmentation (1261); No Apparent Adverse Event (3189); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Parkell, inc.Became aware of an incident involving a parkell insert, the dura30-us, on march 9, 2026.The insert was in use by a student when it broke off in a patient's mouth.It was caught in the trap and immediately suctioned out.No injury was initially reported.No treatment was sought.Images of the insert were provided for evaluation.The insert was returned without the tip.The insert is part of the student instrument package.As part of the resolution, the hygiene coordinator at the university was instructed to remind clinical students to adhere to the performance guide to ensure proper device handling and usage parameters, minimizing the risk of mechanical fatigue or breakage.We are filling this report in an abundance of caution to comply with 21 cfr 803.10(c).We will file a follow-up report if we become aware of any additional relevant information.

• Brand Name: PARKELL
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): PARKELL, INC; 300 executive drive; edgewood NY 11717
• Manufacturer (Section G): PARKELL, INC; 300 executive drive; eedgewood NY 11717
• Manufacturer Contact: patricia beja ; 300 executive drive; edgewood, NY 11717 ; 6313891542
• MDR Report Key: 24794385
• Report Number: 2411797-2026-00002
• Device Sequence Number: 8858464
• Product Code: ELC
• UDI-Device Identifier: 00810000522927
• UDI-Public: 00810000522927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K950256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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
• Operator of Device: Other
• Device Model Number: DURA30-US
• Device Catalogue Number: DURA30-US
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown