ENDOMAT UP210Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04048551376041), received between Sep 13, 2021 and Jul 10, 2026 — classified as 4 deaths, 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Moisture Damage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786910 ↗
• InjuryMay 8, 2026Output Problem; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED: "ON (B)(6) 2026 AT 09:00, IN OPERATING ROOM 3, THE PATIENT UNDERWENT HYSTEROSCOPY AND ENDOMETRIAL LESION RESECTION UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, WHILE USING THE GYNECOLOGICAL SHAVER, THE ENDOSCOPIC IRRIGATION AND SUCTION DEVICE EXPERIENCED A DISPLAY INTERFACE MALFUNCTION, PREVENTING NAVIGATION TO THE NEXT SCREEN AND FAILING TO ASPIRATE TISSUE NORMALLY. THE DEVICE WAS IMMEDIATELY POWERED OFF AND RESTARTED, AND MAINTENANCE PERSONNEL WERE NOTIFIED. AFTER THE RESTART, THE DEVICE RETURNED TO THE NORMAL INTERFACE BUT SUBSEQUENTLY TRIGGERED A FAULT ALARM AGAIN. THE PHYSICIAN CHANGED THE SPECIMEN COLLECTION METHOD, MANUALLY USING A SUCTION CANISTER TO ASPIRATE THE TISSUE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126033 ↗
• MalfunctionApr 29, 2025Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE "USER IS EXPERIENCING SOME AIR BUBBLES" DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931271 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE SALINE SUPPLY RAN OUT DURING SURGERY, SO THE NURSE WAS INSTRUCTED TO REPLACE IT. AFTER THE REPLACEMENT, AIR WAS MIXED IN WHEN THE STOPCOCK WAS RELEASED, CAUSING THE SALINE TO FLOW AFTER A DELAY OF SEVERAL SECONDS. THE PATIENT DEVELOPED AIR EMBOLISM AFTER SURGERY, BUT RECOVERED AND WAS DISCHARGED. DUE TO THE ADVERSE CONSEQUENCES FOR THE PATIENT AND THE PROLONGED HOSPITALIZATION THE CASE IS DEEMED REPORTABLE.

  Patient problems: Air Embolism

  MAUDE report 20028133 ↗
• InjuryAug 21, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE SALINE SUPPLY RAN OUT DURING SURGERY, SO THE NURSE WAS INSTRUCTED TO REPLACE IT. AFTER THE REPLACEMENT, AIR WAS MIXED IN WHEN THE STOPCOCK WAS RELEASED, CAUSING THE SALINE TO FLOW AFTER A DELAY OF SEVERAL SECONDS. THE PATIENT DEVELOPED AIR EMBOLISM AFTER SURGERY, BUT RECOVERED AND WAS DISCHARGED. DUE TO THE ADVERSE CONSEQUENCES FOR THE PATIENT AND THE PROLONGED HOSPITALIZATION THE CASE IS DEEMED REPORTABLE.

  Patient problems: Air Embolism

  MAUDE report 20013009 ↗
• InjuryMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ENDOMAT SELECT DIDN'T HAVE ADEQUATE SUCTION DURING A PROCEDURE. THE PROCEDURE COULD NOT BE CONTINUED AND THE CASE WAS SUSPENDED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.SINCE THE SURGERY WAS SUSPENDED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857846 ↗
• MalfunctionMar 7, 2024Problem with Software Installation; Insufficient Device Problem Information; Problem with Software Installation; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ENDOMAT SELECT DIDN'T HAVE ADEQUATE SUCTION DURING A PROCEDURE. THE PROCEDURE COULD NOT BE CONTINUED AND THE CASE WAS SUSPENDED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. SINCE THE SURGERY WAS SUSPENDED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857845 ↗
• DeathJan 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  WHEN THE SURGEON CONNECTED THE TUBING SET 030647-10 TO ENDOMAT SELECT UP210 AND STARTED USING THEM, AIR GOT MIXED IN AND THE FIELD OF VIEW BECAME POOR. AT THIS TIME, WATER WAS BEING SUPPLIED, BUT SUCTION WAS NOT SUFFICIENT. ABOUT 20 MINUTES AFTER THE START OF THE SURGERY, THE PATIENT'S HEART RATE AND BLOOD PRESSURE DECREASED AND SUDDENLY CHANGED. AN ECHOCARDIOGRAM CONFIRMED THAT AIR WAS ENTERING THE RIGHT ATRIUM.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18455754 ↗
• DeathJan 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  WHEN THE SURGEON CONNECTED THE TUBING SET 030647-10 TO ENDOMAT SELECT UP210 AND STARTED USING THEM, AIR GOT MIXED IN AND THE FIELD OF VIEW BECAME POOR. AT THIS TIME, WATER WAS BEING SUPPLIED, BUT SUCTION WAS NOT SUFFICIENT. ABOUT 20 MINUTES AFTER THE START OF THE SURGERY, THE PATIENT'S HEART RATE AND BLOOD PRESSURE DECREASED AND SUDDENLY CHANGED. AN ECHOCARDIOGRAM CONFIRMED THAT AIR WAS ENTERING THE RIGHT ATRIUM.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18455749 ↗
• DeathJan 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  WHEN THE SURGEON CONNECTED THE TUBING SET 030647-10 TO ENDOMAT SELECT UP210 AND STARTED USING THEM, AIR GOT MIXED IN AND THE FIELD OF VIEW BECAME POOR. AT THIS TIME, WATER WAS BEING SUPPLIED, BUT SUCTION WAS NOT SUFFICIENT. ABOUT 20 MINUTES AFTER THE START OF THE SURGERY, THE PATIENT'S HEART RATE AND BLOOD PRESSURE DECREASED AND SUDDENLY CHANGED. AN ECHOCARDIOGRAM CONFIRMED THAT AIR WAS ENTERING THE RIGHT ATRIUM.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18455748 ↗
• DeathJan 5, 2024Infusion or Flow Problem; Lack of Effect; Infusion or Flow Problem; Lack of Effect

  WHEN THE SURGEON CONNECTED THE TUBING SET 030647-10 TO ENDOMAT SELECT UP210 AND STARTED USING THEM, AIR GOT MIXED IN AND THE FIELD OF VIEW BECAME POOR. AT THIS TIME, WATER WAS BEING SUPPLIED, BUT SUCTION WAS NOT SUFFICIENT. ABOUT 20 MINUTES AFTER THE START OF THE SURGERY, THE PATIENT'S HEART RATE AND BLOOD PRESSURE DECREASED AND SUDDENLY CHANGED. AN ECHOCARDIOGRAM CONFIRMED THAT AIR WAS ENTERING THE RIGHT ATRIUM.

  Patient problems: Unspecified Heart Problem; Unspecified Vascular Problem

  MAUDE report 18455689 ↗
• InjuryMay 25, 2023Pumping Stopped; Pumping Stopped

  THE EVENT OCCURRED IN GREAT BRITAIN. IT WAS REPORTED THAT THE STOPCOCK ON THE SHEATH LEAKED DURING USE AND THE PUMP STOPPED WORKING DURING SURGERY. THERE WAS A PROLONGATION OF 1 HOUR AND THEY HAD TO CONVERT TO A MINI-LAPAROTOMY (OPEN SURGERY) TO REMOVE THE PROSTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004246 ↗
• InjuryMay 25, 2023Pumping Stopped; Pumping Stopped

  THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE STOPCOCK ON THE SHEATH LEAKED DURING USE AND THE PUMP STOPPED WORKING DURING SURGERY. THERE WAS A PROLONGATION OF 1 HOUR AND THEY HAD TO CONVERT TO A MINI-LAPAROTOMY (OPEN SURGERY) TO REMOVE THE PROSTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004245 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FURTHER INFORMATION RECEIVED ABOUT THE CONSEQUENCES FOR THE PATIENT: "-(B)(6) 2021: MS T TRANSFER VIA SAMU 15 IN THE HYPERBARIC CHAMBER THEN IN INTENSIVE CARE SURGICAL FOR NON-INVASIVE VENTILATION - NIGHT FROM (B)(6): PATIENT EXTUBATED IN THE NIGHT - (B)(6) 2021: MRI PERFORMED, BEING INTERPRETED BECAUSE OF THE OBSERVATION OF HYPOTONIA OF THE ARM - SUSPICION OF AN ISCHEMIC HEART PROBLEM - THE ANATOMO-PATHOLOGICAL SAMPLE IS SENT TO THE LABORATORY FOR ANALYSIS." (MFR'S. INTERNAL COMPLAINT (B)(4)).

  Patient problems: Air Embolism; Ischemic Heart Disease

  MAUDE report 12975621 ↗
• InjurySep 13, 2021Use of Device Problem; Improper Flow or Infusion; Use of Device Problem; Improper Flow or Infusion

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): IT WAS REPORTED THAT THE CUSTOMER USED AN ARTHROSCOPY SETUP ENDOSCOPE SETUP FOR A HYSTEROSCOPY. SINCE THE ARTHROSCOPY SOFTWARE IS NOT INTENDED FOR THIS TYPE OF TREATMENT, THE CUSTOMER PROVOKED AN EMBOLISM. ACCORDING TO CUSTOMER'S INFORMATION, THE PATIENT HAS RECOVERED COMPLETELY.

  Patient problems: Embolism/Embolus

  MAUDE report 12460147 ↗