MJOULE
Report
- Report Number
- 2953696-2024-00038
- Event Type
- Injury
- Date Received
- September 10, 2024
- Date of Event
- August 9, 2024
- Report Date
- September 9, 2024
- Manufacturer
- SCITON INC.
- Product Code
- GEX
- UDI-DI
- 00863249000329
- PMA / PMN Number
- K101916
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 117
Narratives
ON 08/13/2024: SCITON CLINICIAL RN REVIEWED THE IMAGES AND SUSPECTS A COUPLE OF BLISTERS. SCITON CLINICAL RN WAS INFORMED BY THE CLINIC THAT THE PATIENT HAS BEEN PRESCRIBED CLOBETASOL, AND SILVADENE MEDICATIONS. ON 08/16/2024: THE SYSTEM WAS CHECKED BY SCITON SERVICE TO INVESTIGATE WHY THE MACHINE WOULD NOT START AT SAFE START PROTOCOL AS REPORTED BY THE SCITON CLINICAL TRAINER. THE SYSTEM WAS TURNED ON AND OFF MULTIPLE TIMES DURING SERVICE VISIT TO TRY AND DUPLICATE THE REPORTED ISSUE AT FLUENCE 5 J/CM2 AND 3MS PULSE WIDTH WITH THE 515 FILTER IN USER MODE. THE SERVICE ENGINEER COULD NOT DUPLICATE THE ISSUE. DEVICE WAS INSPECTED AND NO DEVICE ISSUES WERE FOUND DURING THE INSPECTION. ON 09/09/2024: SCTION CONTACTED THE CLINIC AND WAS INFORMED THAT THE PATIENT IS RECOVERING AND HEALING WELL.
ON 08/12/2024: OWNER OF THE CLINIC CONTACTED SCITON REPRESENTATIVE REPORTING THAT THE PATIENT'S CHEST HAD BURN FOLLOWING MJOULE BBL HEROIC TRAINING ON (B)(6) 2024 WITH 515 NM FILTER. THE PATIENT IS A STAFF MEMBER (NURSE PRACTITIONER) WITH ALLEGEDLY SOME IMMUNOCOMPROMISED ISSUES WITH HER HEALTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2335659 | MJOULE | POWERED LASER SURGICAL INSTRUMENT | GEX | SCITON INC. | MJOULE | 52508 | 00863249000329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |