START-X TIP EMS INSERT 3
Report
- Report Number
- 8031010-2023-00871
- Event Type
- Malfunction
- Date Received
- November 21, 2023
- Report Date
- January 5, 2024
- Manufacturer
- MAILLEFER INSTRUMENTS HOLDING SARL
- Product Code
- ELC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED FOR THE OUTCOME OF THE EVENT: NO FURTHER MEDICAL OR SURGICAL TREATMENT NEEDED; NO PATIENT INJURY. SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1771681). NO INFORMATION WAS GIVEN REGARDING TECHNIQUE, WE CANNOT RULE ON ITS COMPLIANCE WITH MAILLEFER'S RECOMMENDATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION 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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
IN THIS EVENT IT IS REPORTED THAT START-X TIP EMS INSERT 3 TIP BROKE DURING USE. 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 |
|---|---|---|---|---|---|---|---|
| 1854719 | START-X TIP EMS INSERT 3 | SCALER, ULTRASONIC | ELC | MAILLEFER INSTRUMENTS HOLDING SARL | 1771681 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |