X8000 0220200000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327051360), received between May 23, 2018 and Sep 25, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Optical Problem

  It was reported that during a hysteroscopic endometrial polypectomy combined with cervical polypectomy procedure under general anesthesia, the light source host unit of the laparoscopic system suddenly emitted an abnormal noise, followed by an interruption of light source output and complete loss of surgical field illumination, which directly compromised the ongoing surgical procedure. The surgical team immediately suspended the procedure and replaced the light source with a backup unit, restoring the surgical field illumination and allowing the surgery to proceed. The patient's vital signs remained stable throughout, and no adverse patient outcome was observed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897974 ↗
• MalfunctionJun 21, 2022Optical Problem; Optical Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14762423 ↗
• MalfunctionNov 2, 2021Output Problem; Energy Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741187 ↗
• MalfunctionOct 12, 2021Smoking

  IT WAS REPORTED THAT THE DEVICE WAS EMITTING SMOKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615255 ↗
• MalfunctionNov 19, 2020Electrical /Electronic Property Problem; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10871261 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT BURN.

  Patient problems: Burn(s)

  MAUDE report 10544021 ↗
• MalfunctionFeb 27, 2020No Display/Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT (IMAGE) DURING A PROCEDURE. PLEASE NOTE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9764291 ↗
• MalfunctionJan 29, 2020Smoking; Adverse Event Without Identified Device or Use Problem; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: Burn, Thermal; No Patient Involvement

  MAUDE report 9644503 ↗
• InjuryOct 2, 2019Unintended Power Up; Adverse Event Without Identified Device or Use Problem; Unintended Power Up

  IT WAS REPORTED THAT A PATIENT WAS BURNED.

  Patient problems: Burn(s)

  MAUDE report 9147973 ↗
• MalfunctionMay 3, 2019No Display/Image

  IT WAS REPORTED THAT THE PRODUCT LOST IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8578207 ↗
• MalfunctionJan 29, 2019Sparking

  IT WAS REPORTED THAT THERE WAS SPARKING AT THE BULB ASSEMBLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286603 ↗
• MalfunctionMay 23, 2018Smoking

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS SMOKING; THERE WAS NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7539403 ↗