MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-11-17 for SUPERTORQUE HANDPIECE 625CD 0553.0690 manufactured by Kavo Dental.
[548074]
A dentist reported that, while drilling with a 625cd handpiece to remove a band, the bur came out of the handpiece, and was swallowed by the pt. The pt went to the hospital where an endoscope showed the bur in the pt's stomach. The pt rec'd an x-ray to confirm the location of the bur. It was reported that, the bur was not removed from the pt, and was advised by the attending physician to allow the bur to pass. It should be noted that, the pt was not admitted to the hospital. Add'l info rec'd by the manufacturer from the dental office on 11/06/2006 revealed that, the bur had passed, and the pt had not experienced any injury as a result of swallowing the bur.
Patient Sequence No: 1, Text Type: D, B5
[7919948]
The actual unit involved in the incident was returned for evaluation. The head of the handpiece was observed to be damaged due to a dent at the one o'clock position. The shell of the handpiece was observed to be loose at the knee joint and was missing a set screw for the coupling. The handpiece was disassembled for further analysis and it was observed that the bearings were worn and gritty. The chuck which holds the bur was noted to slip and wobble as a result of the dents in the head. A moderate level of debris was also observed inside of the handpiece. The manufacturer contacted the dental office and was provided instruction relative to proper care and maintenance of the handpiece. The dental office was also advised to return any handpiece that had been dented to the mfr for repair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2006-00007 |
| MDR Report Key | 788080 |
| Report Source | 05 |
| Date Received | 2006-11-17 |
| Date of Report | 2006-10-18 |
| Date of Event | 2006-10-17 |
| Date Mfgr Received | 2006-10-18 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2006-12-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIR |
| Manufacturer Street | 901 WEST OAKTON STREET |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERTORQUE HANDPIECE |
| Generic Name | HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL |
| Product Code | EKK |
| Date Received | 2006-11-17 |
| Returned To Mfg | 2006-11-06 |
| Model Number | 625CD |
| Catalog Number | 0553.0690 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 775820 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 EAST MAIN ST. LAKE ZURICH IL 60047 US |
| Baseline Brand Name | SUPERTORQUE HANDPIECE |
| Baseline Generic Name | HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL |
| Baseline Model No | 625CD |
| Baseline Catalog No | 0553.0690 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-17 |