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

Model Number UI25SS10

Device Problem Material Fragmentation (1261)

Patient Problem Bowel Perforation (2668)

Event Date 04/24/2019

Event Type  Injury  

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 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
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618 5935
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618 5935
• Manufacturer Contact: stephanie wasielewski ; 3232 n rockwell st.; chicago, IL 60618-5935
• MDR Report Key: 9418237
• MDR Text Key: 185257864
• Report Number: 1416605-2019-00020
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075484
• UDI-Public: (01)10889950075484(10)1106
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K012060
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 74