Olympus WA47506SRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 14042761085042), received between Jan 8, 2019 and Apr 20, 2026 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (18 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Jun 8, 2023Open, Classified

   Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

   Z-2413-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Twisted/Bent

  IT WAS REPORTED THE HF-RESECTION ELECTRODE PLASMALOOP'S DISTAL END WAS BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926388 ↗
• InjuryApr 8, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC SUBMUCOSAL MYOMECTOMY, THE ELECTRODE WAS DAMAGED AND FELL OFF INTO THE UTERUS. THE FALLEN OFF PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ELECTRODE DEVICE, RESULTING IN A DELAY OF ABOUT 30 MINUTES. A REOPERATION WAS PERFORMED AT AN UNKNOWN TIME, AND PERFORATION OF THE UTERUS WAS CONFIRMED. THE CUSTOMER REPORTED THAT IT WAS UNCLEAR WHETHER THE REOPERATION WAS CAUSED BY THE DAMAGED ELECTRODE. REPORT 1 OF 2.

  Patient problems: Perforation

  MAUDE report 24821441 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC SUBMUCOSAL MYOMECTOMY, THE ELECTRODE BROKE. IT WAS REPORTED THAT NO PART OF THIS DEVICE FELL INTO THE UTERUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ELECTRODE DEVICE, RESULTING IN A DELAY OF ABOUT 30 MINUTES. REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821143 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD THE LOOP CUT DURING A THERAPEUTIC TCR PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561111 ↗
• MalfunctionMar 4, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSVAGINAL ENDOSCOPIC MYOMECTOMY FOR UTERINE FIBROIDS, THE ELECTRODE WAS BENT WHEN IT WAS PRESSED DURING DETACHING THE FIBROID. THE TIP OF ELECTRODE FELL OFF INTO THE UTERUS. THE PROCEDURE WAS COMPLETED BY RETRIEVING THE FALLEN OFF PIECE AND REPLACING WITH SAME DEVICE. THERE WAS NO HEALTH HAZARD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512707 ↗
• MalfunctionFeb 27, 2026Material Deformation

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474479 ↗
• MalfunctionFeb 20, 2026Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405554 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 24345540 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE HAD A BENT DISTAL END WHEN IT WAS TAKEN OUT OF THE PACKAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC HYSTEROSCOPIC POLYPECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755839 ↗
• MalfunctionAug 8, 2025Material Deformation; Material Deformation

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750458 ↗
• InjuryJul 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22408091 ↗
• MalfunctionMar 27, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE DISTAL END OF THE LOOP WAS BENT INTO A V SHAPE. THE ISSUE OCCURRED DURING A SETUP FOR A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708951 ↗
• MalfunctionMar 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BOTH THE LEFT AND RIGHT SIDES OF THE RESECTION ELECTRODE LOOP CAME OFF. THIS ISSUE OCCURRED DURING A THERAPEUTIC POLYMERASE CHAIN REACTION (PCR) PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527220 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED, THE ELECTRODE'S TIP WAS CRUSHED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014373 ↗
• InjuryJan 5, 2024Break; Break

  DURING A THERAPEUTIC TRANS CERVICAL RESECTION IN SALINE (TCRIS) PROCEDURE, THE TIP OF THE HF-RESECTION ELECTRODE BROKE WHEN IT WAS ENERGIZED AND FELL INTO THE PATIENT'S UTERUS. THE FALLEN PIECE WAS COLLECTED AND THE UTERUS WAS CLEANED. THE DOCTOR REPLACED THE DEVICE WITH ANOTHER HF-RESECTION ELECTRODE (SAME MODEL) AND COMPLETED THE SURGERY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460593 ↗
• MalfunctionNov 13, 2023Break; Break

  OLYMPUS RECEIVED MEDWATCH MW5146204 BY EMAIL ON OCTOBER 17, 2023. THE MEDWATCH STATES THAT DURING A CYSTOSCOPY PROCEDURE, THE PLASMA LOOP BROKE DURING USE. THE LOOP WAS RETRIEVED WITHOUT COMPLICATIONS, NO RETAINED OBJECTS. THERE WERE NO REPORTS OF HARM. THERE WERE NO REPORTS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125745 ↗
• MalfunctionApr 4, 2023Break; Break

  THE CUSTOMER REPORTED, DURING THE TRANS CERVICAL RESECTION IN SALINE PROCEDURE THE LOOP WIRE WAS CUT OFF WHEN OUTPUT WAS PERFORMED TWICE USING THE HIGH FREQUENCY RESECTION ELECTRODE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ELECTRODE FROM THE SAME LOT. THE ELECTROSURGICAL GENERATOR SETTING VALUE WAS AT 120WATTS. AFTER REPLACING THE ELECTRODE, 100WATTS SETTING WAS USED. NO DEATH OR INJURY WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678148 ↗
• MalfunctionMar 3, 2023Partial Blockage; Material Twisted/Bent; Partial Blockage; Material Twisted/Bent

  IT WAS REPORTED TO OLYMPUS THAT A HF-RESECTIONELECTRODE WAS DISTORTED AND THAT THERE WAS A CATCH WHEN PASSING THE SHEATH. AT THE TIME OF INSPECTION BEFORE USE. IT WAS CONFIRMED AND REPLACED WITH ANOTHER ONE, AND THE PLANNED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479558 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC HYSTEROSCOPIC MYOMECTOMY PROCEDURE, WHEN HIGH-FREQUENCY OUTPUT WAS PERFORMED FOR THE FOURTH TIME TO RESECT MYOMA, THE PATIENT SUSTAINED A UTERINE PERFORATION AND THE PERFUSATE LEAKED INTO THE ABDOMINAL CAVITY. THE PERFORATION WAS SUTURED LAPAROSCOPICALLY DURING SURGERY BUT THE PROCEDURE WAS PROLONGED BY APPROX. 1.5 HOURS AS A RESULT. THERE WAS NO REPORT ABOUT A MALFUNCTION OF ANY OF THE MEDICAL DEVICES USED DURING THE PROCEDURE.

  Patient problems: Uterine Perforation

  MAUDE report 16425621 ↗
• MalfunctionDec 15, 2022Separation Problem; Separation Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", LOOP, 24 FR., STANDARD, 12°-30°, FOR TCRIS (SINGLE USE), THE ELECTRODE LOOP CAME OFF THE END OF THE ELECTRODE AND STUCK INSIDE THE PATIENT¿S TISSUE (UTERUS). THE LOOP WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE (UTERINE MYOMECTOMY BY RESECTION), THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988687 ↗
• MalfunctionOct 12, 2022Melted; Material Split, Cut or Torn; Melted; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH NOTED THE REPORTED EVENT (LOOP APPEARED TO BE MELTED ON THE SIDE OF ELECTRODE) OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WHEN THE BREAKAGE AND THE REPORTED EVENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587706 ↗
• MalfunctionAug 15, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE THE LOOP WIRE AT THE DISTAL END OF THE RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223572 ↗
• InjuryFeb 24, 2022Break; Break

  OLYMPUS WAS INFORMED OF THE FOLLOWING EVENT FROM (B)(6) HEALTH SERVICES ((B)(6) MDIP#(B)(4)): DURING A THERAPEUTIC FIBROID RESECTION, THE TIP OF THE OLYMPUS ELECTRODE LOOP BROKE INSIDE THE PATIENT. THE TIP OF THE DEVICE WAS RETRIEVED FROM THE PATIENT WITH AN UNSPECIFIED SURGICAL INSTRUMENT. THE INTENDED SURGERY WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS AN UNSPECIFIED SURGICAL DELAY TO REMOVE THE FRAGMENT AND GET A NEW DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596314 ↗
• MalfunctionDec 14, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF ELECTRODE BROKE. IT IS UNCLEAR IF ANY FRAGMENTS FELL INTO THE PATIENT AND IF SO, WHETHER ANY FRAGMENTS MAY HAVE REMAINED INSIDE THE PATIENT. HOWEVER, NO FRAGMENTS COULD BE LOCATED INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12997093 ↗
• MalfunctionOct 26, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM IN SALINE (TCRIS) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE. IT IS UNKNOWN WHETHER THE LOOP WIRE JUST BROKE OR A FRAGMENT BROKE OFF AND FELL INTO THE PATIENT¿S UTERUS. HOWEVER, AN X-RAY WAS TAKEN WHERE NO FOREIGN OBJECTS WERE FOUND INSIDE THE PATIENT¿S UTERUS. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. NEVERTHELESS, THIS CAUSED FEELINGS OF ANXIETY IN THE PATIENT AS SHE WAS ONLY UNDER LOCAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697265 ↗