MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-16 for PROTAPER UNIVERSAL OVEN HTR-PTU manufactured by Dentsply Tulsa Dental Specialties.
[22455252]
While no serious injury resulted in this event, if this malfunction recurred, it could cause our contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[22455253]
In this event it was reported that a protaper universal oven was smoking, shorted out and has frayed wires.
Patient Sequence No: 1, Text Type: D, B5
[26855014]
Power cord wires broken and shorting out, and part of the outer sheath is missing. Holders won't latch. Heating tubes clogged with gutta percha. All other functions work properly. Replaced power cord and holders. Cleaned gutta percha, as much as possible, from heat tubes. Unit passed heat test. All other functions normal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2015-00010 |
| MDR Report Key | 4926170 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-08-19 |
| Date Added to Maude | 2015-07-20 |
| 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 | 3 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTAPER UNIVERSAL OVEN |
| Generic Name | GUTT-PERCHA |
| Product Code | EKM |
| Date Received | 2015-07-16 |
| Returned To Mfg | 2015-07-06 |
| Catalog Number | HTR-PTU |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-16 |