Foot Switch for UES-40 MAJ-1258Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170165481), received between Dec 26, 2016 and Oct 21, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "OUTCOMES OF SURGICAL HYSTEROSCOPY: 25 YEARS OF OBSERVATIONAL STUDY," PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING AN ELECTROSURGICAL UNIT. THE AIM OF THIS PROSPECTIVE STUDY WAS TO ANALYZE THE COMPLICATIONS OF OPERATIVE HYSTEROSCOPY OVER THE LAST 25 YEARS AND DETERMINE WHETHER SUCH COMPLICATIONS WERE RELATED TO PATIENT CHARACTERISTICS, SURGERY TYPE, SURGICAL TIME OR DISTENSION-MEDIUM BALANCE. THREE THOUSAND AND SIXTY-THREE OPERATIVE HYSTEROSCOPIES WERE PERFORMED; 52.7% WERE POLYPECTOMIES AND 31.5% WERE MYOMECTOMIES. MYECTOMIES HAD THE HIGHEST INCIDENCE OF COMPLICATIONS, AT 14%, FOLLOWED BY SEPTOLYSIS, AT 6.9%. THE MOST COMMON COMPLICATIONS WERE MECHANICAL (52%). MYOMECTOMIES HAD SEVEN TIMES HIGHER RISK THAN POLYPECTOMIES OF DISTENSION-MEDIUM COMPLICATIONS (RR 7.5, P<.001) BUT THREE TIMES LOWER RISK OF MECHANICAL COMPLICATIONS (RR 0.32, P<.001). THE HIGHEST INCIDENCE OF COMPLICATIONS OCCURRED IN TYPE I MYOMAS AND THOSE LARGER THAN 3 CM. IF WE DEFINE FLUID-BALANCE COMPLICATIONS AS ONLY THOSE PATIENTS WHO ABSORBED MORE THAN 1.5 L AND DEVELOPED RELATED SYMPTOMS, OUR OVERALL COMPLICATION RATE, INCLUDING ALL MECHANICAL COMPL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyponatremia; Unspecified Reproductive System or Breast Problem; Uterine Perforation; Vesicovaginal Fistula

  MAUDE report 15653216 ↗
• InjuryMay 18, 2022Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTS DURING A TRANSURETHRAL RESECTION IN SALINE (TURIS) PROCEDURE USING AN ELECTRICAL SURGICAL UNIT WITH A FOOT PEDAL, AFTER ABOUT AN HOUR OF USE, THE PHYSICIAN RELEASED THE FOOT PEDAL, BUT THE DEVICE DID NOT DISENGAGE RESULTING IN A HOLE IN THE PATIENT¿S BLADDER. THE OPERATION WAS ABANDONED, AND THE PATIENT WAS SENT TO RECOVERY. THE SURGEON IS A REGULAR USER OF THE EQUIPMENT AND DOES NOT BELIEVE THIS WAS CAUSED BY TO USER ERROR. THE NEXT SCHEDULED MAINTENANCE FOR THE DEVICE WAS DUE (B)(6) 2022. TH DEVICE HAS WORKED FINE ON PRIOR PROCEDURES. THE CUSTOMER HAS REQUESTED A FIELD SERVICE COORDINATOR TO COME IN AND INSPECT THE EQUIPMENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ELECTROSURGICAL UNIT USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE FOOT PEDAL USED IN THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 14428366 ↗
• InjuryDec 11, 2019Defective Device; Defective Device

  DURING THE UNSPECIFIED PROCEDURE WITH THE SUBJECT FOOT SWITCH MAJ-1258 AND UES-40, THE USER PRESSED THE PEDAL OF THE SUBJECT FOOT SWITCH MAJ-1258 TO ACTIVATE THE HIGH FREQUENCY OUTPUT, HOWEVER THE HIGH FREQUENCY OUTPUT WAS NOT ACTIVATED. THE USER REPLACED THE FOOT SWITCH MAJ-1258 AND UES-40 TO ANOTHER UNSPECIFIED DEVICE TO COMPLETE THE PROCEDURE. DURING THE INSPECTION OF THE USER WITH THE SUBJECT FOOT SWITCH MAJ-1258 AND UES-40, WHEN THE USER PRESSED THE PEDAL OF THE SUBJECT FOOT SWITCH MAJ-1258, THE USER RECEIVED A SMALL ELECTRIC SHOCK. THE LOCAL SERVICE ENGINEER REPORTED THE FOLLOWING INSPECTION RESULT OF THE SUBJECT FOOT SWITCH MAJ-1258 AND UES-40. THE INSULATION OF OUTSIDE OF LEAD WIRE OF THE SUBJECT FOOT SWITCH MAJ-1258 HAD BEEN PULLED AWAY FROM THE LEAD WIRE. THERE WAS NO ABNORMALITY OF THE UES-40. THERE WAS NO REPORT OF THE INJURY OTHER THAN ABOVE.

  Patient problems: Electric Shock

  MAUDE report 9448984 ↗
• MalfunctionDec 26, 2016No Device Output; No Device Output

  DURING THE PANHYSTERECTOMY WITH THE SUBJECT FOOT SWITCH MAJ-1258 AND UES-40, THE USER FACILITY PRESSED THE CUT PEDAL OF SUBJECT FOOT SWITCH TO ACTIVATE THE HIGH FREQUENCY OUTPUT, HOWEVER THE HIGH FREQUENCY OUTPUT WAS NOT ACTIVATED. THE USER FACILITY CYCLED THE POWER OF THE SUBJECT UES-40 AND THE USER FACILITY PRESSED THE CUT PEDAL OF SUBJECT FOOT SWITCH TO ACTIVATE THE HIGH FREQUENCY OUTPUT, HOWEVER THE HIGH FREQUENCY OUTPUT WAS NOT ACTIVATED. THE USER FACILITY PRESSED THE COAGULATION PEDAL OF SUBJECT FOOT SWITCH TO ACTIVATE THE HIGH FREQUENCY OUTPUT, THE SUBJECT UES-40 NORMALLY ACTIVATED THE HIGH FREQUENCY OUTPUT. THE USER FACILITY REPLACED THE SUBJECT UES-40 WITH THE SURGICAL TISSUE MANAGEMENT SYSTEM (ESG-400) AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN REPLACING THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6204294 ↗