MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE S609 C; DENTAL HANDPIECE

Model Number S609 C

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not sent in, yet.Hence a root cause analysis could not be performed.As soon as the product is available a follow up report will be supplied.

Event Description

The dental office informed that during a treatment the bur came loose and fell into patients mouth who swallowed it.Further details have not been supplied, yet.

Manufacturer Narrative

After several approaches to the dental office and even a visit by company representative the customer was not able to locate the complained handpiece.The location of the handpiece is not known.Therefore an analysis could not be performed.

• Brand Name: SMARTTORQUE S609 C
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 9502252
• MDR Text Key: 196218406
• Report Number: 3003637274-2019-00044
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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: S609 C
• Device Catalogue Number: 1.008.1644
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1