Olympus WA47787ARecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 14042761086261), received between Jan 29, 2021 and Feb 4, 2026 — classified as 19 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC, HYSTEROSCOPIC RESECTION OF FIBROID UNDER GENERAL ANESTHESIA. THE BIPOLAR ELECTRODE BROKE OFF WITHIN THE UTERINE CAVITY AND WAS RETRIEVED BY POLYP FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ELECTRODE OF THE SAME MODEL WITH A DELAY OF LESS THAN 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258840 ↗
• InjuryDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT HALFWAY THROUGH A THERAPEUTIC TRANSCERVICAL RESECTION IN SALINE PROCEDURE UNDER GENERAL ANESTHESIA, WHILE THE USER WAS DOING A RESECTION OF THE SUBMUCOSAL UTERINE FIBROIDS, THE LOOP DETACHED FROM THE ALIGNMENT AND WAS FOUND IN THE UTERINE CAVITY. THE LOOP WAS RETRIEVED COMPLETELY AND SUCCESSFULLY THROUGH AN OPERATIVE HYSTEROSCOPE UNDER X-RAY GUIDANCE USING GRASPING FORCEPS. THE PATIENT UNDERWENT AN UNPLANNED X-RAY IMAGING WITHOUT CONTRAST DYE. THE PROCEDURE WAS PROLONGED MORE THAN 30 MINUTES DUE TO THE ISSUE; HOWEVER, IT WAS COMPLETED PROMPTLY, EFFICIENTLY, AND SUCCESSFULLY AFTER THE INCIDENT. THE PATIENT REMAINED STABLE INTRAOPERATIVELY AND POSTOPERATIVELY ON THE DAY OF THE SURGICAL PROCEDURE AND WAS DISCHARGED THE SAME DAY. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863985 ↗
• InjuryNov 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23468628 ↗
• InjuryAug 27, 2025Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903502 ↗
• InjuryAug 27, 2025Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903500 ↗
• MalfunctionAug 26, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SUBJECT DEVICE MALFUNCTIONED WHEN THE GYNECOLOGIST WITHDREW AND PLACED THE RESECTOSCOPE ON THE TABLE; SHE NOTICED THAT THE LOOP OR TIP OF THE ELECTRODE HAD COME LOOSE AND FALLEN ONTO THE TABLE. THE ISSUE OCCURRED AFTER A THERAPEUTIC TRANSCERVICAL RESECTION OF MYOMA/POLYP (TCR - M/P) PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE DEVICE WAS NO LONGER USED ON THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893818 ↗
• InjuryAug 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE TRANSCERVICAL RESECTION OF A FIBROID, A SIGNIFICANT FLUID DEFICIT OF APPROXIMATELY 6,200 MILLILITERS (ML) OCCURRED. INITIALLY, FLUID INPUT AND OUTPUT WERE BALANCED FOR THE FIRST 6 LITERS; HOWEVER, MID-PROCEDURE, THE METAL LOOP OF THE RESECTOSCOPE FRAGMENTED AND BECAME EMBEDDED IN THE FIBROID, COMPLICATING RETRIEVAL AND NECESSITATING CONTINUOUS IRRIGATION WITH ADDITIONAL FLUID SETS THAT WERE NOT COMMUNICATED DURING THE TEAM BRIEF. THE NUMBER OF FLUID BAGS BEING USED WAS ANNOUNCED, BUT THIS WAS NOT ACKNOWLEDGED, LIKELY DUE TO THE CRITICAL FOCUS ON LOCATING THE MISSING LOOP. BECAUSE NO ONE WAS DELEGATED TO MONITOR FLUID BALANCE, FLUID OUTPUT WAS NOT SUCTIONED OR RECORDED PROMPTLY DURING THIS PERIOD. AFTER RETRIEVING THE LOOP AND AT THE ANESTHETIST'S REQUEST, A PAUSE WAS CALLED TO CALCULATE FLUID BALANCE, REVEALING THAT APPROXIMATELY 13,000 ML HAD BEEN INFUSED WITH ONLY 6,800 ML ACCOUNTED FOR IN OUTPUT, RESULTING IN THE DEFICIT. IT WAS NOTED THAT THE PROCEDURE WAS PROLONGED BY GREATER THAN OR AT LEAST 30 MINUTES. EDEMA WAS NOTED BY THE ANESTHETIST, AND THE SURGEON DECIDED TO ABANDON THE PROCEDURE FOR PATIENT SAFETY. THERE WERE NO REPORTS OF FURTHER PATIE

  Patient problems: Abnormal Blood Gases; Swelling/ Edema

  MAUDE report 22797255 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THE RESECTOSCOPE EXPERIENCED BROKEN ELECTRODES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22526627 ↗
• InjuryJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC TRANS-CERVICAL RESECTION OF ENDOMETRIUM, THE ELECTRODE LOOP DETACHED AND FELL INSIDE THE PATIENT'S UTERUS. EXPLORATION OF THE BODY CAVITY WAS DONE, AND THE LOOP WAS RETRIEVED BY FLUSHING IT OUT WITH FLUID. THE PROCEDURE WAS PROLONGED BY LESS THAN 30 MINUTES AND WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161274 ↗
• InjuryMay 22, 2025Break; Break

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072142 ↗
• MalfunctionApr 29, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926109 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THE LOOPS BROKE DURING A THERAPEUTIC RESECTION OF FIBROID PROCEDURE. THERE WAS A LESS THAN A 30 MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO ADVERSE HEALTH CONSEQUENCES AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762708 ↗
• MalfunctionMar 27, 2025Break; Break

  NO ADDITIONAL INFORMATION FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707780 ↗
• InjuryFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE ELECTRODE WAS DETACHED. THE PATIENT UNDERWENT AN ULTRASOUND PROCEDURE TO LOCATE THE TIP WHICH WAS THEN REMOVED WITH ANOTHER OPERATION. THE PROCEDURE HAS BEEN COMPLETED USING A SIMILAR DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338248 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT DURING A THERAPEUTIC POLYP RESECTION, THE DEVICE BROKE. DURING THE FIRST CUT, THE LOOP BENT AND THEN BROKE ON THE SECOND CUT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045904 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING TRANS CERVICAL RESECTION IN SALINE PROCEDURE, THE SUBJECT DEVICE BROKE WHILE INSIDE THE PATIENT. A MEDICAL INTERVENTION WAS DONE TO RETRIEVE THE BROKEN PART SUCCESSFULLY. AS THE PHYSICIAN WAS FINISHING THE PROCEDURE, THE LOOP BROKE OFF AGAIN. THERE WAS NO INDICATION THAT THE SECOND DEVICE BROKE INSIDE THE PATIENT. THIS RESULTED TO A PROCEDURAL DELAY OF MORE THAN 30 MINUTES. THE PROCEDURE WAS THEN COMPLETED WITH THE USE OF A SIMILAR DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031209 ↗
• InjuryDec 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031200 ↗
• InjuryDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP DETACHED WHILE BEING USED DURING A GYNECOLOGICAL RESECTION PROCEDURE WHICH CAUSED 2 HOURS OF DELAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LOOP AND THE PATIENT WILL NEED XRAY AND BE SEEN AGAIN IN 2 MONTHS. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20867681 ↗
• InjuryNov 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DURING A GYNECOLOGICAL PROCEDURE-HYSTEROSCOPIC ENDOSCOPY FOR MYOMA, THE ELECTRODE WAS LOOSENED AND DETACHED THAT FELL INTO THE PATIENT'S UTERINE CAVITY. REPORTEDLY, THE SLING DID NOT SLIDE INTO THE TROCAR AND LIQUID SUPPLY STOPPED DURING COMBUSTION. THE GYNECOLOGIST COULD NOT FIND THE PART OF DEVICE INSIDE PATIENT AND THUS SCOPED THE PATIENT (WITHOUT A SLEEVE INTO THE VAGINAL CAVITY) AND SEARCHED FOR THE DEVICE WITHOUT ANY SUCCESS, WHEREIN THERE WAS NO FLOW. ALSO, AN X-RAY WAS UNDERTAKEN, THE SLING WAS VISIBLE INSIDE THE UTERINE CAVITY. THE PROCEDURE WAS DELAYED BY 20 MINUTES AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. A WEEK LATER, THE PATIENT CAME IN FOR AN OUTPATIENT HYSTEROSCOPY FOR RETRIEVAL OF DEVICE. REPORTEDLY THE PATIENT DEVELOPED UTERINE INFECTION ON (B)(6) 2024, AND PATIENT HAD FEVER, THE C-REACTIVE PROTEIN WAS ELEVATED, BLOOD AND BODY FLUIDS WERE CULTURED. CULTURES WERE NEGATIVE, AND PATIENT HAD LOW ABDOMINAL PAIN. INFECTION WAS CONFIRMED AND PATIENT RECEIVED THE FOLLOWING TREATMENT. (B)(6) 2024 IV ZINACEF 1.5G 1X3 J, IV METRONIDAZOLE 400MG 1X3. (B)(6) 2024 KEFEKSIN 750 X3, PO METRONIDAZOLE (FLAGYL) 400 X3. (B)(6) 2024 KEFEKSIN 500MG X3, PO METRO

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 20599167 ↗
• InjuryOct 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A TRANSCERVICAL RESECTION OF FIBROIDS (TCRF) PROCEDURE, ONE BIPOLAR RESECTION LOOP BROKE AND WAS FISHED OUT WITH A SECOND BIPOLAR RESECTION LOOP THAT ALSO BROKE DURING THE PROCEDURE. THE FIRST BROKEN LOOP (WIRE PIECE) WAS FOUND, BUT THE SECOND ONE WAS NOT SEEN ON THE SCREEN. THE PROCEDURE TO FIND THE MISSING WIRE TIP WAS ABANDONED. THE PATIENT WOULD RETURN IN 6 WEEKS FOR A SECOND PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20354717 ↗
• InjuryOct 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A TRANSCERVICAL RESECTION OF FIBROIDS (TCRF) PROCEDURE, ONE BIPOLAR RESECTION LOOP BROKE AND WAS FISHED OUT WITH A SECOND BIPOLAR RESECTION LOOP THAT ALSO BROKE DURING THE PROCEDURE. THE FIRST BROKEN LOOP (WIRE PIECE) WAS FOUND, BUT THE SECOND ONE WAS NOT SEEN ON THE SCREEN. THE PROCEDURE TO FIND THE MISSING WIRE TIP WAS ABANDONED. THE PATIENT WOULD RETURN IN 6 WEEKS FOR A SECOND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354573 ↗
• InjurySep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE UNSPECIFIED PROCEDURE WAS STOPPED, AND THE DEVICE TIP WAS TAKEN OUT OF THE PATIENT. THERE WAS NO FURTHER INFORMATION PROVIDED DESPITE MULTIPLE REQUESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292944 ↗
• InjurySep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE TIP COULD NOT BE SUCCESSFULLY TAKEN OUT SO THE UNSPECIFIED PROCEDURE WAS STOPPED. AN X-RAY WAS OBTAINED POST OPERATIVELY. THERE WAS NO FURTHER INFORMATION PROVIDED DESPITE MULTIPLE REQUESTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20292920 ↗
• InjurySep 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC RESECTION OF MULTIPLE SUBMUCOSAL FIBROIDS, THE RESECTOSCOPE ELECTRODE LOOP ARM SNAPPED. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND REPLACED. THE PROCEDURE CONTINUED AND THEN BOTH ARMS OF THE SECOND RESECTOSCOPE ELECTRODE LOOP SNAPPED. THE DEVICE PART WAS FOUND VIA HYSTEROSCOPY AND REMOVED FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129630 ↗
• InjurySep 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC RESECTION OF MULTIPLE SUBMUCOSAL FIBROIDS, THE RESECTOSCOPE ELECTRODE LOOP ARM SNAPPED. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND REPLACED. THE PROCEDURE CONTINUED AND THEN BOTH ARMS OF THE SECOND RESECTOSCOPE ELECTRODE LOOP SNAPPED. THE DEVICE PART WAS FOUND VIA HYSTEROSCOPY AND REMOVED FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129577 ↗