MAUDE Adverse Event Report: AMERICAN EAGLE INSTRUMENTS INC. EAGLE CLAW XP HAND SCALING UNIT; SCALER, ULTRASONIC

Model Number EAGLE CLAW XP

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 07/31/2017

Event Type  malfunction  

Event Description

Pt was having periodontal procedure done when the hand scaler had a piece break off and possibly be swallowed by the pt.

• Brand Name: EAGLE CLAW XP HAND SCALING UNIT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): AMERICAN EAGLE INSTRUMENTS INC.; missoula
• MDR Report Key: 6787564
• MDR Text Key: 82623596
• Report Number: MW5071507
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2017

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 Model Number: EAGLE CLAW XP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR