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 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

Unfortunately, only the prophyflex handpiece without the affected cannula has been sent in for analysis.For the test of the product a new cannula has been used.It was not possible to identify any abnormality related to the locking mechanism.If the cannula gets inserted and locked as requested by ifu it is not possible to remove it.Therefore, the most likely explanation for the loss of the cannula during the treatment is either that it has not been locked correctly prior to the treatment or that it has been unlocked by mistake during the treatment.Another possibility is that the cannula itself has an defect which causes an insufficient locking.To avoid such incidents the ifu contains already warnings and notes about the use of the product: inserting the cannula; insert the cannula into the handpiece, and turn it clockwise in the direction of the arrow up to the limit stop.Caution: the marks must coincide or the cannula can become detached.If the cannula comes off during treatment, it could substantially endanger the patient and user.Pull on the cannula and check its firm seating before each treatment.Before each treatment, make sure that the cannula operates properly.

Event Description

During a standard dental prophylaxis cleaning procedure the cannula of the powder-blasting- handpiece (prophyflex handpiece) separated from the main body of the handpiece, fell into patients mouth, and was swallowed by her.No further information has been supplied.

• 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: 9255233
• MDR Text Key: 219163397
• Report Number: 3003637274-2019-00037
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K973876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2009
• 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