MAUDE Adverse Event Report: KAVO DENTAL GMBH GENTLEPOWER LUX CONTRA ANGLE 25LPR; DENTAL HANDPIECE

Model Number 25LPR

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

After sterilizing the handpiece the assistance wanted to remove the burr out of the handpiece.When she tried to do so the head became loose from the body and the bur pierced her hand.It was bleeding a little bit and therefore she applied a bandaid.No medical care was necessary.

Manufacturer Narrative

The analysis did show that a rubber cover from a third party was used on the head of the handpiece which made the handling more difficult.It was also found that the ball bearings have been gritty.It was not possible to duplicate the problem.The issue shows that the maintenance is not performed as requested by the ifu.The burr should be removed directly after the use of the handpiece, before the handpiece gets cleaned, disinfected, lubricated and sterilized.Also the rubber cap should be removed before the whole procedure to ensure that the parts are clean and maintained as requested.

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach 88400 ; GM 88400 ; 351561356
• MDR Report Key: 4360811
• MDR Text Key: 5239763
• Report Number: 3003637274-2014-00040
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/15/2014

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: 25LPR
• Device Catalogue Number: 1.007.3580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: 30 YR