Olympus WA47706SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 14042761085530), received between Oct 6, 2022 and Mar 10, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THE RESECTION ELECTRODE PLASMA LOOP THE LOOP BROKE OFF INSIDE THE PATIENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC RESECTION OF A FIBROID PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559220 ↗
• MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE HF-RESECTION ELECTRODE "PLASMALOOP" HAD THE METAL LOOP GET DISLODGED INSIDE THE CANNULA SHEATH OF RESECTOSCOPE INTRAOPERATIVELY. THE METAL LOOP WAS FOUND OUTSIDE THE PATIENT'S OPERATIVE SITE AND WAS DISCARDED. THIS MALFUNCTION OCCURRED DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466659 ↗
• MalfunctionJun 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337173 ↗
• InjuryFeb 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC HYSTEROSCOPIC RESECTION OF A POLYP, THE LOOP BROKE OFF. AN X-RAY WAS PERFORMED TO LOCATE THE BROKEN PIECE, BUT THE SEARCH WAS UNSUCCESSFUL. THE ROOM WAS DELAYED BY SIXTY-FOUR MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21452917 ↗
• MalfunctionMay 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE RESECTION ELECTRODE'S PLASMA LOOP BENT. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE. THE INTENDED PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248266 ↗
• InjuryMar 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE LOOP BROKE AT THE END OF THE PROCEDURE AND WAS REMOVED BY TRAPPING THE WIRE WITH THE END OF THE RETRACTABLE LOOP ARM WITHOUT ANY CAUTERY ACTIVATED. ANOTHER SURGEON THEN PROCEEDED WITH THE PATIENT'S BREAST SURGERY. THERE WAS NO DELAY AS THE X-RAY WAS DONE AT THE END OF THE COMPLETED CASES, NOT IN BETWEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988746 ↗
• InjuryMar 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE LOOP BROKE AT THE END OF THE PROCEDURE AND WAS REMOVED BY TRAPPING THE WIRE WITH THE END OF THE RETRACTABLE LOOP ARM WITHOUT ANY CAUTERY ACTIVATED. ANOTHER SURGEON THEN PROCEEDED WITH THE PATIENT'S BREAST SURGERY. THERE WAS NO DELAY AS THE X-RAY WAS DONE AT THE END OF THE COMPLETED CASES, NOT IN BETWEEN. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988466 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION ELECTRODE'S LOOP BECAME DETACHED FROM THE BODY OF THE ELECTRODE. THE ISSUE WAS FOUND AS THE SURGEON WAS ABOUT TO INITIATE USE ON THE PATIENT FOR A HYSTEROSCOPIC RESECTION OF FIBROID. THE DEVICE WAS REMOVED FROM THE SURGICAL FIELD BEFORE USE ON THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410173 ↗
• InjuryOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A THERAPEUTIC HYSTEROSCOPIC MYOMECTOMY, THE LOOP ON THE HF-RESECTION ELECTRODE BROKE OFF AND NEEDED TO BE REMOVED BY GRASPERS CAUSING THE CASE TO BE DELAYED BY 25 MINUTES. THE DOCTOR MENTIONED THE LOOP IS FLIMSY AND WEAK AND THIS IS THE SECOND LOOP ELECTRODE THAT HAS BROKEN ON HIM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM WAS REPORTED. RELATED PATIENT IDENTIFIER: (B)(6) (SN: (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939240 ↗
• InjuryOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A THERAPEUTIC HYSTEROSCOPIC MYOMECTOMY, THE LOOP ON THE HF-RESECTION ELECTRODE BROKE OFF AND NEEDED TO BE REMOVED BY GRASPERS CAUSING THE CASE TO BE DELAYED BY 25 MINUTES. THE DOCTOR MENTIONED THE LOOP IS FLIMSY AND WEAK AND THIS IS THE SECOND LOOP ELECTRODE THAT HAS BROKEN ON HIM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT HARM WAS REPORTED. RELATED PATIENT IDENTIFIER: (B)(6) (WA47706S / SN: UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939141 ↗
• InjuryOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A THERAPEUTIC HYSTEROSCOPIC MYOMECTOMY, THE LOOP ON THE HF-RESECTION ELECTRODE BROKE OFF AND COULD NOT BE LOCATED IN THE RESECTED TISSUE OR THE UTERUS. AN X-RAY AND ULTRASOUND WERE PERFORMED, AND THE BROKEN LOOP COULD NOT BE VISUALIZED. THIS ADDED ABOUT 45 MINUTES OF TIME TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LOOP AND THE PATIENT IS DOING WELL POST-OP WITH NO ISSUES THUS FAR. THE PATIENT WAS INFORMED AND TOLD TO KEEP AN EYE ON A PIECE OF METAL THAT MAY COME OUT POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17939063 ↗
• InjurySep 7, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE HF-RESECTION ELECTRODE "PLASMALOOP" WAS MISSING AFTER BEING USED IN A PATIENT DURING A HYSTEROSCOPY WITH FIBROID RESECTION. THE LOOP WAS THERE WHEN INSERTING DEVICE AND WHEN REMOVING, THE LOOP WAS MISSING. IT WAS STATED THAT THE LOOP BROKE INSIDE THE PATIENT AND WAS NOT RETRIEVABLE, AND IT POTENTIALLY WAS RETAINED BY THE PATIENT. AN X-RAY AFTER THE PROCEDURE AND A THOROUGH EXAMINATION OF THE UTERUS WAS DONE, BUT THEY WERE UNABLE TO VISUALIZE OR LOCATE THE MISSING PORTION. IT WAS STATED THAT THE PROCEDURE WAS UNABLE TO BE COMPLETED. ADDITIONAL FOLLOW UP WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17699301 ↗
• MalfunctionAug 22, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT A BROKEN PIECE OF A HF-RESECTION ELECTRODE "PLASMALOOP", NEEDED TO BE RETRIEVED. THE EVENT OCCURRED DURING THE PROCEDURE AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596845 ↗
• InjuryAug 3, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HF-RESECTION ELECTRODE "PLASMALOOP", LOOP BROKE OFF WHILE RESECTING THE UTERINE FIBROID DURING A HYSTERECTOMY MYOMECTOMY, AND HAD TO BE REMOVED BY GRASPERS. THE PROCEDURE WAS EXTENDED BY 10 MINUTES AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450969 ↗
• InjuryMar 30, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING TWO DIFFERENT THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR, THIS RESECTION ELECTRODE LOOPS BROKE. THE FIRST CASE, THE LOOP BROKE COMPLETELY OFF. THE SECOND CASE, THE LOOP BROKE IN HALF. BOTH PROCEDURES WERE PROLONGED DUE TO THE NEED TO OBTAIN REPLACEMENT LOOPS AND VERIFY THE BROKEN PIECES WERE NOT LEFT IN THE PATIENT. THE FIRST CASE WAS 1 3/4 HOURS AND THE SECOND CASE 2 HOURS. IN BOTH OCCURRENCES, THE LOOP WAS REMOVED SUCCESSFULLY AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING A SIMILAR DEVICE. X-RAYS WERE OBTAINED TO CONFIRM BROKEN PIECES WERE NOT LEFT IN THE PATIENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIERS: (B)(6) 1ST CASE OF 2 BROKEN RESECTION ELECTRODE LOOP. (B)(6) 2ND CASE OF 2 BROKEN RESECTION ELECTRODE LOOP. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653125 ↗
• MalfunctionMar 3, 2023Break; Break

  AS REPORTED BY THE CUSTOMER "LOOPS BROKE INSIDE PATIENT DURING PROCEDURE (THERAPEUTIC). ACCORDING TO THE REPORT, THE INTENDED PROCEDURE WAS COMPLETED, NOTED THAT THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. PER THE REPORT, THE REPORTED PROBLEM DID NOT HAVE AN IMPACT TO THE OUTCOME OF THE PROCEDURE. NO PATIENT HARM OR INJURY, NO USER INJURY REPORTED DUE TO THE EVENT. THE EVENT REPORTED OCCURRED TO BE ON THE SAME DEVICE MODEL (QUANTITY OF 3) WITH TWO ARE THE SAME LOT (2 LOTS 1000100402 AND LOT 1000099745). THIS EVENT INCLUDES THREE (3) REPORTS TO CAPTURE THE THREE LOTS REPORTED TO FAIL DURING PROCEDURE. REPORT WITH PATIENT IDENTIFIER (B)(6), WA47706S, 1000099745. REPORT WITH PATIENT IDENTIFIER (B)(6), WA47706S, 1000100402. REPORT WITH PATIENT IDENTIFIER (B)(6), WA47706S, 1000100402. THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) WA47706S, 1000100402.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476639 ↗
• MalfunctionMar 3, 2023Break; Break

  AS REPORTED BY THE CUSTOMER "LOOPS BROKE INSIDE PATIENT DURING PROCEDURE (THERAPEUTIC). ACCORDING TO THE REPORT, THE INTENDED PROCEDURE WAS COMPLETED, NOTED THAT THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. PER THE REPORT, THE REPORTED PROBLEM DID NOT HAVE AN IMPACT TO THE OUTCOME OF THE PROCEDURE. NO PATIENT HARM OR INJURY, NO USER INJURY REPORTED DUE TO THE EVENT. THE EVENT REPORTED OCCURRED TO BE ON THE SAME DEVICE MODEL (QUANTITY OF 3) WITH TWO ARE THE SAME LOT (2 LOTS 1000100402 AND LOT 1000099745). THIS EVENT INCLUDES THREE (3) REPORTS TO CAPTURE THE THREE LOTS REPORTED TO FAIL DURING PROCEDURE. REPORT WITH PATIENT IDENTIFIER: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476594 ↗
• MalfunctionMar 3, 2023Break; Break

  AS REPORTED BY THE CUSTOMER "LOOPS BROKE INSIDE PATIENT DURING PROCEDURE (THERAPEUTIC). ACCORDING TO THE REPORT, THE INTENDED PROCEDURE WAS COMPLETED, NOTED THAT THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. PER THE REPORT, THE REPORTED PROBLEM DID NOT HAVE AN IMPACT TO THE OUTCOME OF THE PROCEDURE. NO PATIENT HARM OR INJURY, NO USER INJURY REPORTED DUE TO THE EVENT. THE EVENT REPORTED OCCURRED TO BE ON THE SAME DEVICE MODEL (QUANTITY OF 3) WITH TWO ARE THE SAME LOT (2 LOTS 1000100402 AND LOT 1000099745). THIS EVENT INCLUDES THREE (3) REPORTS TO CAPTURE THE THREE LOTS REPORTED TO FAIL DURING PROCEDURE. REPORT WITH PATIENT IDENTIFIER: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476563 ↗
• InjuryOct 6, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS DURING A HYSTEROSCOPY MYOMECTOMY (RESECTION OF A UTERINE FIBROID) THE LOOP BROKE. THE LOOP BROKE COMPLETELY OFF THE ELECTRODE AND WAS LOST IN THE UTERUS FOR APPROXIMATELY 5-10 MINUTES. IT WAS LOCATED AND REMOVED USING A 5.5MM HYSTEROSCOPE AND GRASPERS. A 2ND LOOP WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED "SEVERAL BROKEN LOOPS PREVIOUSLY." A REQUEST FOR ADDITIONAL INFORMATION IN PROGRESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15555901 ↗