MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC Hu-Friedy; SCALER, ULTRASONIC

Model Number	UI25SS10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No material issue was found.The insert was well past its life expectancy based on the age of the instrument (manufactured in september 2006).The conclusion is that the instrument was used past its expected life expectancy which is 1 year.
Event or Problem Description
During a dental scaling procedure the scaler tip broke off (approx.2cm broke off) and was swallowed.Patient was sent to a hospital and an x-ray scan was performed and revealed that the scaler tip was inside patient.Patient was later admitted to the hospital for observation for 2 days.Patient found himself excreting blood in late (b)(6) 2019.Such symptom continued over a course of few days before subsiding and it was suspected that the blood excretion was due to the scaler tip perforating the lining of his bowel and/ or irritating his prior operation site.Patient returned on (b)(6) 2019 for a follow up session and was told that the scaler tip had likely been passed out naturally as the tip was no longer found in his body.

• Brand Name: Hu-Friedy
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618 5935
• MDR Report Key: 9418237
• Report Number: 1416605-2019-00020
• Device Sequence Number: 2450370
• Product Code: ELC
• UDI-Device Identifier: 10889950075484
• UDI-Public: (01)10889950075484(10)1106
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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
• Operator of Device: Health Professional
• Device Model Number: UI25SS10
• Device Catalogue Number: UI25SS10
• Device Lot Number: 1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 74