Maquet ORCHIDE ARD568803952Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712415976), received between Oct 23, 2023 and Oct 23, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Peeled/Delaminated; Peeled/Delaminated

  ON 11TH JANUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. BASED ON PHOTOGRAPHIC EVIDENCE THE LABEL ON CAMERA (CAT. NO. ARD568803952) WAS DAMAGED WITH MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE SUBJECT MATTER EXPERTS INDICATED THAT DURING SURGERY, A STERILIZABLE HANDLE IS PLACED ON AND AROUND THE CAMERA LIKE A "SLEEVE" OR "MUFF", AS A PROTECTION, SO THERE IS NO RISK OF FALLING COMPONENT ONTO A PATIENT DURING SURGERY AND A POSSIBLE FALLING OF THIS SMALL CHIPPING FROM THE LABEL INVOLVED COULD NOT LEAD TO ANY (POTENTIAL) INJURY TO PATIENT, USER OR OTHER PERSON. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE IS NO RISK OF LABEL PARTICLES FALLING TO THE STERILE FIELD, CAUSING A CONTAMINATION, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984957 ↗