Olympus WA47786ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 14042761086254), received between May 28, 2021 and Mar 10, 2026 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 24558382 ↗
• InjuryMar 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC RESECTION OF A TROPHOBLASTIC RETENTION, THE LOOP OF THE RESECTION DEVICE BROKE. IT BECAME STUCK IN THE RETENTION AND WAS RECOVERED UNDER HYSTEROSCOPY AFTER A LONG SEARCH. THE DURATION OF THE OPERATION WAS EXTENDED, WITH NO REPORTS OF FURTHER PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526752 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THE LOOP OF THE ENDOSCOPIC ELECTROSURGICAL ELECTRODE SNAPPED WHILE BEING INSERTED INTO THE RESECTION OPENING PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE ISSUE OCCURRED DURING A RESECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489507 ↗
• InjuryJun 8, 2023Break; Break

  IT WAS ADDITIONALLY REPORTED THAT THE PROCEDURE WAS A HYSTEROSCOPY AND THAT THE PATIENT HAD A GOOD POST SURGICAL RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17090368 ↗
• InjuryJun 8, 2023Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING THE VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING, THE DISTAL END OF THE LOOP BROKE IN THE PATIENT 30 MINUTES INTO THE PROCEDURE. THE LOOP WAS NOT FOUND. THE PROCEDURE CONTINUED WITH A SECOND LOOP, WHICH ALSO BROKE. THE PROCEDURE WAS THEN ABANDONED/INTERRUPTED. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS DUE TO THE POTENTIAL INFECTION RISK. IT WAS STATED THAT THE PHYSICIAN DID NOT FEEL THERE WAS A RISK OF UTERINE PERFORATION OR ANY OTHER SERIOUS INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED. THIS EVENT REQUIRES TWO REPORTS FOR THE TWO BROKEN LOOPS. PATIENT IDENTIFIER'S (B)(6) AND (B)(6). THIS REPORT IS FOR (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 17090241 ↗
• MalfunctionApr 14, 2023Flare or Flash; Flare or Flash

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING THE VERSAPOINT II ELECTROSURGICAL GENERATOR, NON-STERILE, REUSABLE FOR A MYOMECTOMY, FOUR (4) LOOPS WERE OPENED FOR THE CASE. THE FIRST LOOP BURNED THROUGH WHILE "ACTIVATED." THE SURGEON MANAGED TO GET THE METAL PART OUT (PRESUMABLY OUT OF THE BODY) BY CURETTING IT OUT AND WASHING IT OUT WITH SALINE UNDER PRESSURE. THREE OTHER LOOPS WERE OPENED, AND ALL BURNED THROUGH THE CENTER OF THE LOOP BEFORE ATTEMPTING TO USE THE LOOP TO CUT. A NEW GENERATOR WAS BROUGHT IN AND THE CASE WAS FINISHED WITH A LOOP WITHOUT ANY FURTHER PROBLEMS. THE FIRST GENERATOR HAD BEEN SERVICED 3 WEEKS PRIOR TO THE CASE. HOWEVER, WHEN THE TECHNICIAN WENT OUT TO THE FACILITY THE DAY AFTER THE ISSUES WERE NOTED, THE GENERATOR WAS ON THE MAXIMUM SETTING OF 200, WHICH WAS PAST THE DEFAULT SETTING OF 170. IT WAS STATED THAT THE STAFF HAD NOT CHANGED ANY SETTINGS AND THEY USE THE DEFAULT SETTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS EVENT REQUIRES 5 REPORTS. (B)(6) IS FOR A VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING (FIRST LOOP). (B)(6) IS FOR A VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING (S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743612 ↗
• MalfunctionApr 14, 2023Flare or Flash; Flare or Flash

  HOLD SAC 4/21 A USER FACILITY REPORTED TO OLYMPUS, THAT WHILE USING THE VERSAPOINT II ELECTROSURGICAL GENERATOR, NON-STERILE, REUSABLE FOR A MYOMECTOMY. FOUR (4) LOOPS WERE OPENED FOR THE CASE. THE FIRST LOOP BURNED THROUGH WHILE "ACTIVATED". THE SURGEON MANAGED TO GET THE METAL PART OUT (PRESUMABLY OUT OF THE BODY) BY CURETTING IT OUT AND WASHING IT OUT WITH SALINE UNDER PRESSURE. THREE OTHER LOOPS WERE OPENED, AND ALL BURNED THROUGH THE CENTER OF THE LOOP BEFORE ATTEMPTING TO USE THE LOOP TO CUT. A NEW GENERATOR WAS BROUGHT IN AND THE CASE WAS FINISHED WITH A LOOP, WITHOUT ANY FURTHER PROBLEMS. THE FIRST GENERATOR HAD BEEN SERVICED 3 WEEKS PRIOR TO THE CASE. HOWEVER, WHEN THE TECHNICIAN WENT OUT TO THE FACILITY THE DAY AFTER THE ISSUES WERE NOTED, THE GENERATOR WAS ON THE MAXIMUM SETTING OF 200, WHICH WAS PAST THE DEFAULT SETTING OF 170. IT WAS STATED, THAT THE STAFF HAD NOT CHANGED ANY SETTINGS AND THEY USE THE DEFAULT SETTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS EVENT REQUIRES 5 REPORTS: (B)(6) IS FOR A VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING (FIRST LOOP). (B)(6) IS FOR A VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743483 ↗
• MalfunctionApr 14, 2023Flare or Flash; Flare or Flash

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING THE VERSAPOINT II ELECTROSURGICAL GENERATOR, NON-STERILE, REUSABLE FOR A MYOMECTOMY, FOUR (4) LOOPS WERE OPENED FOR THE CASE. THE FIRST LOOP BURNED THROUGH WHILE "ACTIVATED." THE SURGEON MANAGED TO GET THE METAL PART OUT (PRESUMABLY OUT OF THE BODY) BY CURETTING IT OUT AND WASHING IT OUT WITH SALINE UNDER PRESSURE. THREE OTHER LOOPS WERE OPENED, AND ALL BURNED THROUGH THE CENTER OF THE LOOP BEFORE ATTEMPTING TO USE THE LOOP TO CUT. A NEW GENERATOR WAS BROUGHT IN AND THE CASE WAS FINISHED WITH A LOOP WITHOUT ANY FURTHER PROBLEMS. THE FIRST GENERATOR HAD BEEN SERVICED 3 WEEKS PRIOR TO THE CASE. HOWEVER, WHEN THE TECHNICIAN WENT OUT TO THE FACILITY THE DAY AFTER THE ISSUES WERE NOTED, THE GENERATOR WAS ON THE MAXIMUM SETTING OF 200, WHICH WAS PAST THE DEFAULT SETTING OF 170. IT WAS STATED THAT THE STAFF HAD NOT CHANGED ANY SETTINGS AND THEY USE THE DEFAULT SETTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS EVENT REQUIRES 5 REPORTS. (B)(6) IS FOR A VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING (FIRST LOOP). (B)(6) IS FOR A VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING (S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743409 ↗
• InjuryApr 14, 2023Flare or Flash; Flare or Flash

  ADDITIONAL INFORMATION WAS OBTAINED. THE INDICATION FOR THE MYOMECTOMY WAS A LARGE MYOMA FOUND ON SCAN. WHEN ASKED HOW LONG THE DELAY WAS, THE USER FACILITY STATED THAT THE OPERATION TOOK A TOTAL OF 145 MINUTES. THEY WERE UNABLE TO SAY EXACTLY HOW LONG THE DELAY WAS, BUT THAT IT WAS PROBABLY ABOUT 3 MINUTES PER EACH LOOP EXCHANGE. IT WAS ALSO STATED THAT SINCE IT WAS A LARGE FIBROID, IT DID A LONG TIME TO REMOVE IT. THE ANESTHESIOLOGIST KEPT THE PATIENT SEDATED AS PER NORMAL. THE PATIENT HAD NO ADVERSE EFFECTS AND WENT HOME THE NEXT MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743291 ↗
• InjuryDec 9, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE TWO YEARS AGO THE LOOP WIRE AT THE DISTAL END OF THE LOOP ELECTRODE BROKE OFF AND FELL INTO THE PATIENTS BODY CAVITY. THIS WAS NOT NOTICED AT THE TIME OF THE PROCEDURE BUT ONLY RECENTLY. AN X-RAY EXAMINATION CONFIRMED THAT THE LOOP WIRE IS STILL IN THE PATIENT AND A FOLLOW-UP PROCEDURE IS TO BE SCHEDULED TO REMOVE THE BROKEN FRAGMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15948284 ↗
• MalfunctionNov 9, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC MYOMECTOMY PROCEDURE THE DISTAL END OF THE LOOP ELECTRODE BROKE OFF AND FELL INTO THE PATIENT'S UTERUS. HOWEVER, THE BROKEN FRAGMENT COULD BE RETRIEVED SUCCESSFULLY DURING THE SAME PROCEDURE. THE PROCEDURE WAS SLIGHTLY EXTENDED BUT THE USER DID NOT CONSIDER THIS EXTENSION TO BE A SERIOUS DETERIORATION IN THE STATE OF HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757861 ↗
• InjurySep 19, 2022Activation Problem; Activation Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE 2 HF-RESECTION ELECTRODES CAUSED THE GENERATOR TO ISSUE ERROR MESSAGE E200. THE ERROR MESSAGE STILL OCCURRED AFTER THE HF-CABLE AND THE HF-GENERATOR HAD BEEN REPLACED. THE ERROR MESSAGE ONLY DISAPPEARED WHEN A THIRD HF-ELECTRODE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED, HOWEVER THE FAILURE OF THE TWO ELECTRODES LED TO A DELAY OF THE PROCEDURE OF APPROX. 1 HOUR. THERE WAS REPORTEDLY NO IMPACT ON THE PATIENT OTHER THAN THE PROLONGED PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445131 ↗
• InjurySep 19, 2022Activation Problem; Activation Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE 2 HF-RESECTION ELECTRODES CAUSED THE GENERATOR TO ISSUE ERROR MESSAGE E200. THE ERROR MESSAGE STILL OCCURRED AFTER THE HF-CABLE AND THE HF-GENERATOR HAD BEEN REPLACED. THE ERROR MESSAGE ONLY DISAPPEARED WHEN A THIRD HF-ELECTRODE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED, HOWEVER THE FAILURE OF THE TWO ELECTRODES LED TO A DELAY OF THE PROCEDURE OF APPROX. 1 HOUR. THERE WAS REPORTEDLY NO IMPACT ON THE PATIENT OTHER THAN THE PROLONGED PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444998 ↗
• MalfunctionMay 28, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF FIBROIDS (TCRF) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF-RESECTION ELECTRODE DETACHED. THE SURGEON TRIED TO RETRIEVE THE DETACHED PART, BUT WAS UNABLE TO LOCATE IT. IT IS UNKNOWN WHETHER THE DETACHED PART REMAINED INSIDE THE PATIENT¿S BODY SINCE IT COULD NOT BE FOUND WITH AN X-RAY EXAMINATION OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899353 ↗