Slimline™ 200 D/F/L Slimline 200 DFL FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290109140261), received between Feb 28, 2019 and Jun 20, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Break; Break

  IT WAS REPORTED THAT DURING HANDLING OF THIS FIBER LASER, THE FIBER SNAPPED AND PIERCED THE HAND OF THE NURSE. IT WAS SAID THAT THE NURSE WAS REPORTED BE IN GOOD CONDITION AND NO FURTHER TREATMENT WAS NECESSARY. ANOTHER FIBER WAS USED TO CONTINUE THE CASE.

  Patient problems: Burn(s); Laceration(s)

  MAUDE report 19576373 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT THIS DEVICE WAS DAMAGED AS ITS MATERIAL WAS SEPARATED. NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18114844 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN CONNECTING THE FIBER TO THE CONSOLE, THE FIBER BROKE AND DETACHED FROM THE RUBBER CONNECTOR THAT INSERTS INTO THE LASER CONSOLE. ANOTHER FIBER WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT CORRESPONDS TO THE THIRD OF FOUR FIBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629101 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN CONNECTING THE FIBER TO THE CONSOLE, THE FIBER BROKE AND DETACHED FROM THE RUBBER CONNECTOR THAT INSERTS INTO THE LASER CONSOLE. ANOTHER FIBER WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT CORRESPONDS TO THE SECOND OF FOUR FIBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628685 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN CONNECTING THE FIBER TO THE CONSOLE, THE FIBER BROKE AND DETACHED FROM THE RUBBER CONNECTOR THAT INSERTS INTO THE LASER CONSOLE. ANOTHER FIBER WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT CORRESPONDS TO THE FIRST OF FOUR FIBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621068 ↗
• MalfunctionOct 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN CONNECTING THE FIBER TO THE CONSOLE, THE FIBER BROKE AND DETACHED FROM THE RUBBER CONNECTOR THAT INSERTS INTO THE LASER CONSOLE. ANOTHER FIBER WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT CORRESPONDS TO THE FOURTH OF FOUR FIBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620749 ↗
• MalfunctionAug 11, 2022Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE FIBER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214461 ↗
• MalfunctionFeb 9, 2020Failure to Deliver Energy; Failure to Deliver Energy

  ON JANUARY 22, 2020 LUMENIS RECEIVED A USER SUBMITTED MEDWATCH REPORT MW5092013 IN WHICH THE DESCRIPTION OF THE EVENT READS: "DURING A CYSTOSCOPY WITH LASER LITHOTRIPSY AND STENT INSERTION PROCEDURE, A SLIMLINE 200 DFL LASER FIBER WAS OPENED AND ATTACHED TO THE LASER MACHINE; WHEN MD ATTEMPTED TO USE, IT DIDN'T WORK. OPENED NEW FIBER WHICH WORKED WITHOUT ANY PROBLEM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9685083 ↗
• MalfunctionFeb 28, 2019Material Fragmentation; Material Fragmentation

  ON 06-FEB-2019 LUMENIS RECEIVED A USER SUBMITTED MEDWATCH REPORT (REF: MW5082896) IN WHICH THE EVENT DESCRIPTION READS: DURING CYSTOSCOPY WITH RIGHT-SIDED STENT EXCHANGE, LASER LITHOTRIPSY, AND STONE BASKET EXTRACTION - LASER FIBER OF DISTAL PORTION OF THE FIBER BECAME LOOSE. ABLE TO BE TAKEN OUT THROUGH PENIS WITHOUT ANY IDENTIFICATION OF PIECES LEFT WITHIN THE URETHRA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377937 ↗