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SPOTLIGHT 292908109Recalls & reported problems

Medos International Sàrl · SPOTLIGHT ACCESS SYSTEM 9F SUCTION TUBE RETRACTOR ASSEMBLY · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034225913), received between Sep 13, 2019 and Apr 28, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

Most reported problems

Device problems

  • Break2
  • Mechanical Jam1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 28, 2023Mechanical Jam; Mechanical Jam

    IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023, THE SPOTLIGHT LIPPED AND NON-LIPPED SUCTION WAS CONTINUOUSLY CLOGGING. IT WAS SUSPECTED THAT A BEND ON THE SUCTION MAYBE OBSTRUCTED. THIS REPORT IS FOR A SPOT 9F SUCTION TUBE RETRACTOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16832368 ↗
  • MalfunctionFeb 24, 2023Break; Break

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE ON (B)(6) 2023, THE SURGEON WAS USING THE SPOTLIGHT DISCECTOMY SUCTION RETRACTOR AND THE TIP BROKE OFF. THE FRAGMENT WAS RETRIEVED IMMEDIATELY WITHOUT DELAY TO THE SURGERY OR ANY ADVERSE EVENT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPOTLIGHT ACCESS SYSTEM 9F SUCTION TUBE RETRACTOR ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16435148 ↗
  • MalfunctionSep 13, 2019Break; Break

    IT WAS REPORTED THAT ON UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SPOTLIGHT ACCESS SYSTEM 9F SUCTION TUBE RETRACTOR WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9036200 ↗

Other CATHETER AND TIP, SUCTION devices

All CATHETER AND TIP, SUCTION devices →

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