n.a. 20132620-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551062838), received between Jul 14, 2023 and Apr 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Off-Label Use; Unexpected Shutdown; Off-Label Use; Unexpected Shutdown

  IT WAS REPORTED THAT WHEN THE CONCERNED PRODUCT WAS USED IN A VETERINARY PROCEDURE (LAPAROSCOPIC SPAY). IT WAS REPORTED THAT "MID SURGERY THE LIGHT SOURCE TURNED OFF AND WOULD NOT TURN BACK ON. THE BOX WAS VERY HOT TO TOUCH AND ONLY DISPLAYED THE RED WARNING LIGHT ONCE THE LIGHT HAD ALREADY GONE OUT. AS THE LIGHT SOURCE WOULD NOT TURN BACK ON AFTER TRYING EVERYTHING THEY SUGGESTED WE HAD TO CONVERT TO AN OPEN SURGERY WHICH IS NOT WHAT THE CLIENT HAD COME IN FOR." IT WAS CONFIRMED THAT THE SURGERY WAS PROLONGED BETWEEN 15 AND 60 MINUTES AND HAD TO BE CONVERTED FROM LAPAROSCOPIC TO OPEN SURGERY. FURTHERMORE, IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT RECOVERED WELL FROM THE SURGERY AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19136369 ↗
• MalfunctionJul 14, 2023Off-Label Use; Unexpected Shutdown; Off-Label Use; Unexpected Shutdown

  IT WAS REPORTED THAT THE LAMP WAS USED IN A VETERINARY LAPAROSCOPIC SPAY OPERATION OF A DOG. AFTER THE LAMP FAILED, THE OPERATION WAS TURNED IN AN OPEN SURGERY, SO IT TURNS ALSO FROM AN OVARIECTOMY TO AN OVARIOHYSTERECTOMY. THE IFU STATED THAT IT IS ONLY ALLOWED TO USE THE DEVICE IN HUMAN MEDICAL APPLICATION (ESPECIALLY GASTROENTEROLOGY). IN ADDITION, NO EVENT (TIMEFRAME: BETWEEN 2021-06-28 AND 2023-07-11) THAT COULD BE CONSIDERED AS SIMILAR TO THIS ONE AND CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY COULD BE FOUND. ALTHOUGH THE INSTRUMENT WAS USED OFF-LABEL THE CASE DEEMED REPORTABLE BECAUSE THE CASE HAD TO BE CONVERTED TO AN OPEN SURGERY DUE TO THE LOSS OF LIGHT, WHICH COULD ALSO HAPPEN DURING HUMAN APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326741 ↗