Maquet OrchideRecalls & reported problems across all models

We found 5 models of Maquet Orchide by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Oct 20, 2022 and Oct 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Maquet Orchide recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 8, 2023Open, Classified

   A potential for a light system to fall in the operating room.

   Z-0762-2024 · Root cause: Equipment maintenance · names 3 of these models · Recall details · FDA record ↗

Most reported Maquet Orchide problems

Maquet Orchide models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Maquet Orchide ARD569204944

  Camera, Surgical And Accessories
  1 recall2 reports
• Maquet Orchide ARD568803935

  Camera, Surgical And Accessories
  1 recall0 reports
• Maquet Orchide ARD568803967

  Camera, Surgical And Accessories
  1 recall0 reports
• Maquet Orchide ARD568803951

  CAMERA, SURGICAL AND ACCESSORIES
  1 report
• Maquet ORCHIDE ARD568803952

  Camera, Surgical And Accessories
  1 report

Recent Maquet Orchide adverse event reports

The 4 most recent reports across all models, 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 ↗
• MalfunctionJul 27, 2023Peeled/Delaminated; Peeled/Delaminated

  ON 18TH JULY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II. BASED ON PHOTOGRAPHIC EVIDENCE THE LABEL WAS CHIPPING OFF. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403225 ↗
• MalfunctionNov 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6)2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II. AS IT WAS STATED, THE PARTICLES OF THE DAMAGED CAMERA FELL ONTO THE SURGICAL SITE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833685 ↗
• MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6)2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL CAMERA - OHDII AIR03 QL FHD E. IT WAS STATED THE HANDLE CAME OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15637433 ↗

Other Maquet Sas products

• Maquet PowerLED II992 models · 138 reports · 1 recall
• POWERLED TM280 models · 79 reports · 2 recalls
• STANDOP VOLISTA23 models · 56 reports · 1 recall
• Maquet Rolite17 models · 1 reports · 2 recalls
• LUCEA LED33 models · 51 reports · 1 recall
• ROLITE VOLISTA STANDOP8 models · 0 reports · 2 recalls
• Maquet Equipment45 models · 8 reports · 1 recall
• POWERLED2 models · 3 reports · 1 recall