MAUDE Adverse Event Report: KAVO DENTAL GMBH PROPHYFLEX 3 HANDPIECE 2018; DENTAL HANDPIECE

Model Number 2018

Device Problems Detachment of Device or Device Component (2907); Misassembly by Users (3133)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Both, the prophyflex handpiece and the nozzle have been sent in for analysis.No deviations could be found.It was possible to push the nozzle in its support and it was possible to turn the lock mechanism.After locking the nozzle, it was not possible to remove it.Therefore, the most likely root cause for the event is, that the user did not completely lock the nozzle prior to the use.

Event Description

During a standard dental prophylaxis cleaning procedure the nozzle of the powder-blasting- handpiece (prophyflex handpiece) separated from the main body of the handpiece, fell into patients mouth and was swallowed by her.Patient visited the local health care centre where she has been brought into the emergency room to get an x-ray monitoring.It was then noted that the nozzle was in the stomach.Two days later another x-ray has been made, then the nozzle was lying in the gut.Another two days later the nozzle came out on the natural way.No injury to the patient.

• Brand Name: PROPHYFLEX 3 HANDPIECE 2018
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• MDR Report Key: 8939075
• MDR Text Key: 196298690
• Report Number: 3003637274-2019-00035
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K973876
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2018
• Device Catalogue Number: 1.000.4672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 23 YR