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

Model Number 2018

Device Problem Decoupling (1145)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

The customer agreed to send in both, the handpiece and the detached cannula nozzle.But we did not receive them, yet.Therefore a follow-up report will be supplied as soon as the device is available and analysed.

Event Description

During a standard prophylaxis dental 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.As dentist was not sure what happened and as patient was pregnant and therefore x-raying was not possible she was sent to university clinic to have a gastroscopy.The cannula was not detected in stomach during the procedure.It was therefore not clear whether patient really swallowed the part.10 days after the incident it was clear as the part now passed the gastrointestinal passage and left the body on the natural way.There was no injury to patient.

Manufacturer Narrative

The analysis of the product did show that both sides of the bayonet-coupling are within specification - the part of the canula and the part on the handpiece.Also the marks on the outside which indicate that the coupling is locked are in the correct position and good visible.The coupling is mechanically within specification and working as requested.If the canula is attached to the front end of the handpiece it should be turnable in order to adjust the working angle of the canula.For this purpose the front end of the handpiece is normally turnable mounted.At this handpiece the front end was very stiff to turn.Therefore the most likely root cause for this issue is that the user tried to turn the canula to a different working angle.As the front end of the handpiece was so stiff to turn the user did not hold the front end of the handpiece to turn it but held the canula at the distal end as there is a good point to hold it.By turning the canula it was possible to adjust the angle but at the same time the bayonet-coupling got unlocked by mistake.When the user continued the treatment the canula was blown into the patients mouth.Root cause for the stiff front end of the handpiece is a lack of maintenance.The instruction for use contains therefore several notes and warnings: 2.2 safety instructions warning hazard to the care provider and patient.Irregularities in the product.-> stop working and contact service support.3.1 purpose - intended use.Proper use: according to these regulations, this medical device may only be used for the described application by a knowledgeable user.You need to comply with the following: the applicable health and safety regulations, the applicable accident prevention regulations, these instructions for use.According to these regulations, the user is required to: only use equipment that is operating correctly, adhere to the specified intended use protect him or herself, the patient and third parties from danger, and avoid contamination from the product.5.4 inserting the cannula -> insert the cannula into the handpiece, and turn it all the way to the right opposite the direction of the arrow.Caution the marks must be adjacent; otherwise the cannula can come loose.If the cannula comes off during treatment, it could substantially endanger the patient and user.-> pull on the cannula each time before treatment and check its seat.-> before each treatment, make sure that the cannula operates properly.

• Brand Name: PROPHYFLEX 3 HANDPIECE 2018
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400 ; 735156
• MDR Report Key: 5123233
• MDR Text Key: 27308928
• Report Number: 3003637274-2015-00026
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 2018
• Device Catalogue Number: 1.000.4672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2005
• 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: 21 YR