X-SMART PLUS
Report
- Report Number
- 8031010-2024-00893
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Report Date
- February 13, 2024
- Manufacturer
- MAILLEFER INSTRUMENTS HOLDING SARL
- Product Code
- EGS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION OF A SIMILAR DEVICE RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR 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.
INVESTIGATION RESULTS: RECEIVED = 1X X-SMART PLUS CONTRA-ANGLE 6:1 A103300000000 SN: (B)(6); 1X X-SMART PLUS HANDPIECE A103400000300 SN: (B)(6); 1X X-SMART PLUS UNIT SN: (B)(6); 1X X-SMART PLUS UNIV.AC.ADAPTER A103400000200 SN: (B)(6). X-SMART PLUS UNIT; SAV NO DEFECT; NO DEFECT WAS FOUND. FAILURE MODE: AUTOREVERSING IMPROPERLY; ROOT CAUSE: NO DEFECT PROVEN; CONCLUSION CODE: NO FAILURE FOUND. THE OUTCOME OF THIS EVENT NO FURTHER INFORMATION RECEIVED AFTER 3 DOCUMENTED ATTEMPTS.
IN THIS EVENT IT IS REPORTED THAT X-SMART PLUS HAS A PROBLEM WITH AUTO REVERSE FUNCTION OF THE DEVICE. AS A CONSEQUENCE THE DENTIST HAS BROKEN SEVERAL FILES DURING PATIENT TREATMENT. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1574332 | X-SMART PLUS | HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | EGS | MAILLEFER INSTRUMENTS HOLDING SARL | 09801594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |