MAUDE Adverse Event Report: KAVO DENTAL GMBH PROPHYFLEX 2 HANDPIECE 2012; DENTAL HANDPIECE

Model Number 2012

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

Up to now we did not receive the product for analysis and we did not get further information regarding the patient outcome.Also the serial number of the product has not been supplied.As the customer has several of these handpieces we can just estimate the age.As all of them have been produced in 1998 just the month is not clear - which makes no difference regarding the incident.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 2 HANDPIECE 2012
• 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: 10004360
• MDR Text Key: 189216785
• Report Number: 3003637274-2020-00009
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2012
• Device Catalogue Number: 0.573.0730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/1998
• 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: 69 YR