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

Model Number 2018

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

The handpiece has been sent in for analysis.Unfortunately, the nozzle which was involved in the event was not supplied.It was found that the function of the nozzle clamping mechanism was limited by encrusted deposits.In fact, it was very hard to push a new nozzle fully in and to turn it into the lock position.Hence it is very likely that the nozzle was not really installed and locked correctly prior to the use.Certainly, the option exists that the used nozzle had a mechanical defect.Since the nozzle was not supplied, this possibility could not be verified.To avoid such issues the ifu contains already several warnings and notes for a correct handling and maintenance of the product: 2.4 technical condition: a damaged device or components could injure patients, users and third parties.Only operate devices or components if they are undamaged on the outside.Check that the device is working properly and is in satisfactory condition before each use.Have parts with sites of breakage or surface changes checked by the service.Safety checks may only be performed by trained service personnel.If you notice any of the following defects on the product or accessories, stop working and have the service personnel carry out repair work.2.7 service and repair: repairs, servicing and safety checks may only be performed by trained service personnel.The following persons are authorised to do this: service technicians of kavo branches after the appropriate product training.Service technicians of kavo authorised dealers after the appropriate product training observe all the following items during servicing work: have the service and testing tasks carried out according to the medical device operator ordinance.After servicing, interventions on and repairs of the device and before re-use, have the service personnel perform safety checks on the device.Kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check.Define the service interval depending on the frequency of use.Cleansers and disinfectants that have not been approved can damage the plastic housing leading to hairline cracks and other damage which can ultimately lead to hazards.Have a safety check done on the product every 2 years.For this purpose, send the product to the kavo customer service centre warthausen or a test centre approved by kavo.5.4 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 nozzle of the powder-blasting- handpiece (prophyflex handpiece) separated from the main body of the handpiece, fell into patients mouth and was swallowed by him.It was decided to get the part out of the stomach with an endoscope.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, 88400 ; GM 88400
• MDR Report Key: 16608907
• MDR Text Key: 312288441
• Report Number: 3003637274-2023-00003
• 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: User Facility,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2011
• 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: 12 YR
• Patient Sex: Male