n.a. 26040GP1-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04048551392720), received between Jul 14, 2017 and Aug 3, 2026 — classified as 7 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Insufficient Device Problem Information

  It was reported that on (b)(6) 2026, according to the standard surgical procedure, the patient was scheduled to undergo hysteroscopic endometrial lesion resection + hysteroscopic cervical lesion resection + fractional diagnostic curettage + cervical biopsy. During the operation, while using the high-frequency electrosurgical device, the working handpiece suddenly burned through the bipolar electrode cable, causing the patient to experience a brief electric shock. The use of the device was immediately discontinued, and a backup working handpiece and electrode cable were replaced. After confirming no issues, the surgery continued.New additional information was received on July 24, 2026. Based on the new information there are 3 additional potentially causal KARL STORZ products involved in the event and additional reported error description: "The sealing ring leaks, and water flows through the gap to the electrode cable during the procedure."Cross reference MDR:9610617-2026-01599,9610617-2026-01798,9610617-2026-01799.

  Patient problems: Electric Shock

  MAUDE report 50122170 ↗
• MalfunctionMay 7, 2026Break; Fracture

  IT WAS REPORTED THAT "DURING HYSTEROSCOPIC SURGERY, THE DOCTOR USED AN ELECTROSURGICAL CUTTING LOOP TO SEPARATE INTRAUTERINE TISSUE AND COAGULATE BLEEDING POINTS. WHILE THE CUTTING LOOP WAS IN USE INSIDE THE UTERINE CAVITY, A CIRCUMFERENTIAL FRACTURE OCCURRED AT THE FRONT 1.5 CM × 1.5 CM SECTION OF THE LOOP." ACCORDING TO THE AVAILABLE INFORMATION THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A PROLONGATION OF 10 MINUTES AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115813 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT THE TIP BROKE OFF WHILE RESECTING FIBROID IN THE UTERUS. NO PATIENT WAS HARMED. ADDITIONALLY, THEY WERE USING A COVIDIEN FT10 GENERATOR FOR THIS PROCEDURE AND THEY WERE ABLE TO FLUSH THE BROKEN PIECE OUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211548 ↗
• MalfunctionDec 19, 2025Fracture; Sparking; Fracture; Sparking

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH THE CHIEF COMPLAINT OF "PROLONGED MENSTRUAL PERIODS FOR OVER 9 YEARS." ON NOVEMBER 20, UNDER INTRAVENOUS COMBINED ANESTHESIA, THE PATIENT UNDERWENT HYSTEROSCOPIC RESECTION OF A UTERINE LESION (ENDOMETRIAL POLYP RESECTION) + DIAGNOSTIC DILATION AND CURETTAGE + REMOVAL OF AN INTRAUTERINE CONTRACEPTIVE DEVICE. AFTER ROUTINE DRAPING, THE HYSTEROSCOPE WAS INSERTED. WHILE PREPARING FOR ELECTROSURGICAL RESECTION DURING THE PROCEDURE, THE RESECTOSCOPE LOOP SUDDENLY SPARKED. THE HYSTEROSCOPE WAS IMMEDIATELY WITHDRAWN FOR INSPECTION, WHICH REVEALED A FRACTURE AT THE CONNECTOR OF THE DISPOSABLE HYSTEROSCOPIC RESECTOSCOPE. THE PROCEDURE CONTINUED AS PLANNED AFTER REPLACING THE DISPOSABLE HYSTEROSCOPIC RESECTOSCOPE. IT WAS CONFIRMED THAT THE PRODUCT CONCERNED HAS BEEN SCRAPPED BY THE HOSPITAL AFTER BEING DAMAGED AND CANNOT BE RETURNED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851366 ↗
• InjuryOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "A HYSTEROSCOPIC RESECTOSCOPE AND ITS MATCHING RESECTOSCOPE LOOP WERE USED DURING THE PROCEDURE. WHILE RESECTING THE INTRAUTERINE LESION, THE SURGEON OBSERVED A METALLIC STRIP-LIKE OBJECT WITHIN THE UTERINE CAVITY UNDER THE VISUAL FIELD. IMMEDIATE INSPECTION OF THE RESECTOSCOPE LOOP REVEALED THAT APPROXIMATELY 5 MM OF THE FRONT-END METAL RING HAD DETACHED, THOUGH THE INTERNAL WIRE REMAINED CONNECTED. THE DAMAGED LOOP REMNANT WAS PROMPTLY REMOVED ON THE OPERATING TABLE. HOWEVER, DURING RETRIEVAL NEAR THE VAGINAL FORNIX, THE REMNANT DISAPPEARED FROM THE VISUAL FIELD. IT WAS INITIALLY SUSPECTED THAT THE REMNANT HAD BEEN FLUSHED OUT BY THE HYSTEROSCOPIC DISTENSION FLUID, BUT REPEATED EXAMINATIONS OF THE EXTERNAL FLUID COLLECTION BUCKET DID NOT LOCATE THE RESIDUAL FRAGMENT. A C-ARM WAS IMMEDIATELY USED FOR FLUOROSCOPIC EXAMINATION, WHICH CONFIRMED THAT THE METALLIC REMNANT REMAINED WITHIN THE PATIENT'S VAGINA. A SECONDARY SURGICAL INSPECTION WAS IMMEDIATELY PERFORMED, AND THE METALLIC STRIP WAS EVENTUALLY FOUND ON A STERILE GAUZE SPONGE IN THE VAGINAL FORNIX. AFTER SUCCESSFUL RETRIEVAL, COMPARISON CONFIRMED THAT ITS LENGTH AND EDGES MATCHED THE DAMAGED SECTION OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438651 ↗
• InjuryOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "A HYSTEROSCOPIC RESECTOSCOPE AND ITS MATCHING RESECTOSCOPE LOOP WERE USED DURING THE PROCEDURE. WHILE RESECTING THE INTRAUTERINE LESION, THE SURGEON OBSERVED A METALLIC STRIP-LIKE OBJECT WITHIN THE UTERINE CAVITY UNDER THE VISUAL FIELD. IMMEDIATE INSPECTION OF THE RESECTOSCOPE LOOP REVEALED THAT APPROXIMATELY 5 MM OF THE FRONT-END METAL RING HAD DETACHED, THOUGH THE INTERNAL WIRE REMAINED CONNECTED. THE DAMAGED LOOP REMNANT WAS PROMPTLY REMOVED ON THE OPERATING TABLE. HOWEVER, DURING RETRIEVAL NEAR THE VAGINAL FORNIX, THE REMNANT DISAPPEARED FROM THE VISUAL FIELD. IT WAS INITIALLY SUSPECTED THAT THE REMNANT HAD BEEN FLUSHED OUT BY THE HYSTEROSCOPIC DISTENSION FLUID, BUT REPEATED EXAMINATIONS OF THE EXTERNAL FLUID COLLECTION BUCKET DID NOT LOCATE THE RESIDUAL FRAGMENT. A C-ARM WAS IMMEDIATELY USED FOR FLUOROSCOPIC EXAMINATION, WHICH CONFIRMED THAT THE METALLIC REMNANT REMAINED WITHIN THE PATIENT'S VAGINA. A SECONDARY SURGICAL INSPECTION WAS IMMEDIATELY PERFORMED, AND THE METALLIC STRIP WAS EVENTUALLY FOUND ON A STERILE GAUZE SPONGE IN THE VAGINAL FORNIX. AFTER SUCCESSFUL RETRIEVAL, COMPARISON CONFIRMED THAT ITS LENGTH AND EDGES MATCHED THE DAMAGED SECTION OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438649 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP BROKE OFF DURING THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 9610617-2025-01829. 9610617-2025-01830.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351836 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP BROKE OFF DURING THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 9610617-2025-01830. 9610617-2025-01831.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350626 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP BROKE OFF DURING THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDRS: 9610617-2025-01829. 9610617-2025-01831.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350625 ↗
• InjuryAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2025 TWO (2) ELECTRODES BROKE. ACCORDING TO THE DOCTOR, A PIECE WAS RETAINED IN THE PATIENT AND THEY DID NOT SAVE THE BROKEN ELECTRODES. CROSS REFERENCE MEDWATCH NUMBER 2020550-2025-01400.

  Patient problems: Insufficient Information

  MAUDE report 22777209 ↗
• InjuryAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2025 TWO (2) ELECTRODES BROKE. ACCORDING TO THE DOCTOR, A PIECE WAS RETAINED IN THE PATIENT AND THEY DID NOT SAVE THE BROKEN ELECTRODES. CROSS REFERENCE MEDWATCH NUMBER 2020550-2025-01399.

  Patient problems: Insufficient Information

  MAUDE report 22777207 ↗
• InjuryAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2025 TWO (2) ELECTRODES BROKE. ACCORDING TO THE DOCTOR, A PIECE WAS RETAINED IN THE PATIENT AND THEY DID NOT SAVE THE BROKEN ELECTRODES. CROSS REFERENCE MEDWATCH NUMBER 9610617-2025-01400.

  Patient problems: Insufficient Information

  MAUDE report 22777161 ↗
• InjuryAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2025 TWO (2) ELECTRODES BROKE. ACCORDING TO THE DOCTOR, A PIECE WAS RETAINED IN THE PATIENT AND THEY DID NOT SAVE THE BROKEN ELECTRODES. CROSS REFERENCE MEDWATCH NUMBER 9610617-2025-01399.

  Patient problems: Insufficient Information

  MAUDE report 22777151 ↗
• MalfunctionApr 21, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT EQUIPMENT BROKE, IDENTIFIED DURING PROCEDURE BY ATTENDING WHILE OPERATING, NOTICED ON CAMERA SCOPE BIPOLAR CUTTING LOOP NOT WORKING PROPERLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873927 ↗
• MalfunctionNov 18, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE DOCTOR WAS REMOVING BLADDER TUMOR AND NOTICED THERE WAS A BROKEN PIECE OF THE SHEATH INSIDE OF THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712258 ↗
• MalfunctionSep 18, 2024Sparking; Battery Problem; Sparking; Battery Problem

  IT WAS REPORTED DURING A MEDICAL PROCEDURE, THE UNIPOLAR HIGH FREQUENCY CORD POPPED AND SPARKED. NO INJURT WAS NOTED TO THE PHYSICIAN OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246919 ↗
• MalfunctionAug 14, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED DURING A TURBT PROCEDURE ON (B)(6) 2024, THE END OF THE ELECTRODE FELL INTO THE PATIENT'S BLADDER, THE DOCTOR WAS ABLE TO FLUSH THE ELECTRODE OUT. THE PROCEDURE COMPLETED WITH A NEW STERILE SINGLE USE BIPOLAR CUTTING LOOP. NO INJURIES WERE REPORTED AND NO SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985902 ↗
• MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF PROSTATE PROCEDURE ON (B)(6) 2024, THE CUTTING LOOP BROKE OFF INSIDE OF THE PATIENT. THEY WERE ABLE TO REMOVE THE BROKEN PIECE USING A BLADDER EVACUATOR, AND WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP WITHOUT ANY PATIENT INJURY. THIS ISSUE CAUSED A DELAY OF ABOUT 10 MINUTES TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629562 ↗
• MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A BLADDER TUMOR REMOVAL PROCEDURE ON (B)(6) 2024, THE CUTTING LOOP BROKE OFF. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT INJURY, AND WERE ALSO ABLE TO RETRIEVE THE BROKEN PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629241 ↗
• MalfunctionMay 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC POLYPECTOMY OR MYOMECTOMY PROCEDURE ON (B)(6) 2024, THE BIPOLAR CUTTING LOOP BROKE INSIDE OF THE PATIENT. THE YELLOW PIECE WAS RETRIEVED, HOWEVER THE METAL TIP WAS NOT RECOVERED AND WAS PRESUMED LEFT INSIDE THE PATIENT. NO PATIENT INJURY WAS REPORTED. PATIENT IS HOME AND DOING WELL. THE NEXT STEP IS BEING DECIDED.

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

  MAUDE report 19299392 ↗
• MalfunctionNov 24, 2021Break

  DURING PROCEDURE, BIPOLAR LOOP BROKE AT SHAFT.

  Patient problems: Insufficient Information

  MAUDE report 12868561 ↗
• MalfunctionNov 12, 2020Material Separation; Material Separation

  ALLEGEDLY, DURING A TURP PROCEDURE, THE BIPOLAR ELECTRODE LOOP BROKE INSIDE THE PATIENT. THE SURGEON REPORTED THAT THE FRAGMENTED PIECES WERE REMOVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE OUTCOME TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10830451 ↗
• MalfunctionOct 1, 2020Break

  WHILE PERFORMING TURP PROCEDURE, THE SURGEON REPORTED THAT THE BIPOLAR CUTTING LOOP BROKE INTO PIECES INSIDE THE PATIENT. THE FRAGMENTED PIECES WERE REMOVED. MANUFACTURER RESPONSE FOR COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES), N.A. (PER SITE REPORTER). THE REPRESENTATIVE WAS NOTIFIED VIA TELEPHONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10612661 ↗
• MalfunctionJul 23, 2020Material Separation; Material Separation

  ALLEGEDLY, DURING A HYSTEROSCOPIC MYOMECTOMY PROCEDURE, 2-3 MM OF THE BIPOLAR ELECTRODE LOOP BROKE DUE TO THE RESISTANCE OF THE LARGE FIBROMA. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE OUTCOME TO THE PATIENT.

  Patient problems: Fibrosis

  MAUDE report 10317093 ↗
• MalfunctionJan 17, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A SEPTOPLASTY PROCEDURE, ONE OF THE JAWS BROKE OFF INSIDE THE PATIENT. THE PIECE WAS RETRIEVED AND THERE WAS NOT HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8259125 ↗