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SurgiTouch™ ScannerRecalls & reported problems

Lumenis Ltd. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109142975), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Communication or Transmission Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED THAT DURING A PROCEDURE THE CONSOLE DISPLAYED ERROR CODES 74, SCANNER POSITION X AXIS ERROR AND 75, SCANNER POSITION Y AXIS ERROR. SOME OF THE ELEMENTS OF THE PROCEDURE WERE COMPLETED, BUT THEY HAD TO BE LIMITED. IT WAS ALSO REPORTED THAT THE SURGEON SUSTAINED A MINOR BURN INJURY. THE CAUSE OF THE BURN WHILE USING THE EQUIPMENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT BURN TO DATE, DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: Burn(s)

    MAUDE report 23644970 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.