MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA SURGICAL HANDPIECE 3610N2; DENTAL SURGICAL HANDPIECE

Model Number 3610 N2

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

For the analysis the grip sleeve has been removed as necessary for the reprocessing after a treatment.It was clearly visible that there has been residue of blood and tissue.A short test run showed that the bearing at the front end has been defect and therefore there have been clearly vibrations noticeable.After disassembling of the components it was clearly visible that residue of blood and tissue encrusted on the components.All the components including the ball bearings have been completely dry, there has been no sign of a lubricant, which should be after the reprocessing.The whole condition shows that the cleaning-, reprocessing- and maintaining process is not performed according to the requests in the user instruction.

Event Description

During a dental surgical treatment the front end of the handpiece got hot and caused a burn on patients lip.The dentist applied some otc ointment to the burn.There was no medical care necessary.

• Brand Name: INTRA SURGICAL HANDPIECE 3610N2
• Type of Device: DENTAL SURGICAL 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: 5293549
• MDR Text Key: 33403887
• Report Number: 3003637274-2015-00033
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 3610 N2
• Device Catalogue Number: 0.524.5610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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 Age: 14 YR