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

Model Number 3610 N2

Device Problems Device Maintenance Issue (1379); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

The surgical handpiece was received with a bur inserted.Removing the bur on the normal way was not possible.It was also not possible to remove the grip sleeve as it would be necessary after each use for cleaning and reprocessing.After pulling with a high force the grip sleeve and the bur could be detached.It got now visible that the bur stuck in the front bearing of the sleeve due to corrosion and residue of encrusted blood and tissue.Everything was baked together which caused such a high friction that the sleeve already changed color at the front end.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 patient's right cheek.Further details have not been supplied.

• 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
• MDR Report Key: 7236648
• MDR Text Key: 98833188
• Report Number: 3003637274-2018-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2004
• 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: 68 YR