Olympus A22201ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04042761021302), received between Aug 3, 2018 and Jul 7, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THE HF-RESECTION ELECTRODE'S TIP RING OF THE HIGH-FREQUENCY RESECTION ELECTRODE FRACTURED WHEN IT CAME INTO CONTACT WITH METAL OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412406 ↗
• InjuryMar 28, 2024Break; Break

  IT WAS REPORTED, THE SUBJECT DEVICE BROKE OUTSIDE THE PATIENT'S BODY DURING A TRANSURETHRAL RESECTION OF THE BLADDER TUMOR. THE PROCEDURE AND THE PATIENT'S ANESTHESIA WERE PROLONGED BY 1 HOUR AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996533 ↗
• MalfunctionJul 24, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED THAT A SPARK EMITTED FROM A MONOPOLAR HIGH-FREQUENCY CABLE DURING A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY. SMOKE APPEARED AND THE WIRE WAS DISCONNECTED WITH AN EXPLOSION SOUND. THE HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12° WAS ENERGIZED DURING THE OPERATION, BUT THE OUTPUT WAS WEAK, AND AFTER DISCONNECTION, ABOUT 3 CENTIMETERS FROM THE ELECTRODE PART AT THE TIP TO THE PROXIMAL SIDE WAS BURNT AND DARKENED. THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICES. THE DOCTOR HAD A LIGHT BURN ON THEIR HAND, WHICH THEY TREATED BY COOLING IT DOWN, AND HAD NOT TAKEN ANY MEDICATION SINCE THEN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS MDR IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION ON THE HF-RESECTION ELECTRODE LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379321 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED ABOUT A LITERATURE STUDY CALLED "INTRAVESICAL EXPLOSION DURING TRANSURETHRAL RESECTION OF BLADDER TUMOR: A CASE REPORT". THE CASE AT HAND INVESTIGATED ON INTRAVESICAL EXPLOSION DURING TRANSURETHRAL RESECTION OF BLADDER TUMOR (TUR-BT). AFTER SURGERY, NO OBVIOUS DAMAGE WAS FOUND TO THE INTESTINES OR OTHER ABDOMINAL STRUCTURES, BUT A LARGE NUMBER OF BLOOD CLOTS WERE FOUND IN THE BLADDER. FOLLOWING CAREFUL EXPLORATION OF THE BLEEDING SITES AND COMPLETE HEMOSTASIS, THE RESIDUAL TUMOR TISSUE WAS COMPLETELY RESECTED, AFTER WHICH THE BLADDER WAS CHECKED CAREFULLY. A TEST OF BLADDER INFUSION SHOWED NO SUTURE LEAKAGE. THE PELVIC AND ABDOMINAL DRAINAGE TUBES WERE PLACED, AND THE INCISION CLOSED. THIS STUDY CONCLUDES THAT ALTHOUGH RARE, INTRAVESICAL EXPLOSIONS CAN CAUSE SERIOUS CONSEQUENCES, AND THE LOUD EXPLOSION CAN ALSO LEAD TO A PROFOUND PSYCHOLOGICAL SHADOW ON THE PATIENT. CAREFUL OPERATIVE TECHNIQUES AND SPECIAL PRECAUTIONS CAN REDUCE THE RISK OF THIS COMPLICATION. THERE WAS IN TOTAL ONE ADVERSE EVENT (BLADDER RUPTURE) ON ONE PATIENT. HOWEVER, THERE WAS NO MALFUNCTION OF AN OLYMPUS MEDICAL DEVICE REPORTED.

  Patient problems: Rupture

  MAUDE report 16085820 ↗
• MalfunctionNov 18, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT TOWARDS THE END OF AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF INSIDE THE PATIENT. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15823075 ↗
• MalfunctionApr 6, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE, SPARKS OCCURRED DURING COAGULATION AND IT WAS THEN NOTICED THAT THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE HAD BROKE OFF AND FALLEN INTO THE PATIENT. AN X-RAY EXAMINATION WAS PERFORMED BUT THE BROKEN OFF FRAGMENT COULD NOT BE LOCATED. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9927693 ↗
• MalfunctionMar 11, 2020Break; Break

  THE TECHNICAL ASSISTANCE GROUP WAS INFORMED THAT THE LOOP WIRE AT THE DISTAL TIP OF THE HF-RESECTION ELECTRODE FAILED DURING PROCEDURE. THE SALES REPRESENTATIVE REPORTEDLY OBSERVED THE PROCEDURE WHEN THE LOOP WIRE BROKE AFTER THIRTY MINUTES OF USE. THE USER REPLACED THE BROKEN HF-RESECTION ELECTRODE WITH A SECOND-LIKE DEVICE AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE HF-RESECTION ELECTRODE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9816407 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE AT AN UNKNOWN DATE, THE PATIENT SUSTAINED A PERFORATION OF THE UTERUS. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WERE NO REPORTS OF ANY DEVICE MALFUNCTIONS. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.

  Patient problems: Uterine Perforation

  MAUDE report 9097242 ↗
• MalfunctionDec 3, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC HYSTEROSCOPIC MYOMA RESECTION PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED WITH A FORCEPS. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124014 ↗
• MalfunctionAug 3, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TRANSCERVICAL RESECTION OF THE ENDOMETRIUM (TCRE) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF TWO HF RESECTION ELECTRODES BROKE AND ONE OF THEM FELL INSIDE THE PATIENT. THE LOOP WIRE WAS REPORTEDLY NOT RETRIEVED BUT AN EXAMINATION BY X-RAY SHOWED NO FOREIGN OBJECTS INSIDE THE PATIENT. IT WAS ASSUMED THAT THE FRAGMENT WAS POSSIBLY FLUSHED OUT WITH IRRIGATION FLUID. HOWEVER, THE INTENDED PROCEDURE WAS ABORTED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7746146 ↗