MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA LUX HEAD 68LH; HEAD FOR DENTAL HANDPIECE

Model Number 68LH

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

The user sent the product on (b)(6) 2015 to check whether the function is ok.They stated that the head is not able to keep the bur and that it might be a wrong use by the user.It was not stated that the bur has been lost during the treatment and swallowed by patient.Therefore the product has been tested at that time without result.The analysis did not show any deviation from specifications.The chuck system was working as specified.Beginning of (b)(6) 2016 we have been contacted by (b)(6) with the information that the user had reported the described adverse event.This is the reason for the big difference between the date of occurence, the date we received the product for analysis and the date we got aware of the adverse event.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: *insert the contra-angle handpiece drill bit note only use carbide cutters or diamond drill bits that correspond to iso 1797-1 type 1, are made of steel or hard metal and meet the following criteria: - shaft diameter: 2.334 to 2.35 mm - overall length: max.22 mm.*warning use of impermissible cutters or grinders.Injury to the patient or damage to the medical device.> only use cutters or grinders that do not deviate from the indicated data.*caution injury from using worn cutters or grinders.Cutters or grinders can fall out during treatment and injure the patient.> never use cutters or grinders with worn shafts.*caution hazard from defective chucking system.The cutter or grinder can fall out and cause injury.> pull on the cutter or grinder to check if the chucking system is okay and the cutter or grinder is securely held.Wear gloves or a fingerstall to check, insert, or remove the bits to prevent injury and infection.> insert the cutter or grinder into the segment of the head drive by twisting the tool slightly, and push to the stop.> check that the tool is seated by pulling on it.Reported to fda as similar product gets distributed in usa.

Event Description

A dental clinic in (b)(6) complained that the bur which was used for a standard dental treatment was pulled out of the chuck system of the dental handpieces head.It fell into the patients mouth.The patient was asked to spit it out but instead of doing so he swallowed the bur.The patient has been sent to hospital where the bur has been retreived out of the gastrointestinal-tract under anesthetic.

• Brand Name: INTRA LUX HEAD 68LH
• Type of Device: HEAD FOR 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: 5491808
• MDR Text Key: 40043712
• Report Number: 3003637274-2016-00017
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 68LH
• Device Catalogue Number: 0.540.2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2009
• 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