n.a. 27040GP130-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04048551393864), received between Jan 22, 2020 and Apr 14, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT THE LOOP ELECTRODE BROKE OFF INSIDE THE BLADDER OF THE PATIENT. THE DOCTOR RECOVERED THE BROKEN PART AND REMOVED IT FROM THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874710 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT LOOP BROKE OFF INSIDE THE PATIENT. THE LOOP COULD BE REMOVED BY THE SURGEON, BUT THE REMOVAL REQUIRED ADDITIONAL SURGICAL TIME. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702376 ↗
• MalfunctionMar 2, 2026Break

  ACCORDING TO THE INFORMATION RECEIVED, THE CUTTING LOOP FAILED DURING CASE. DR USED ITEM AND A PART OF THE ITEM MELTED OFF. NO PATIENT HARM. NO NOTES ON DELAY OF SURGERY; SURGERY COMPLETED AFTER SWITCHING OUT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482760 ↗
• MalfunctionAug 8, 2025Break; Break

  THE BIPOLAR ELECTRODE BROKE INSIDE OF A PATIENT DURING A PROCEDURE. FOREIGN MATTER WAS REMOVED AND THERE WAS NO HARM TO THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751746 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUTTING LOOP BROKE OFF IN PATIENT DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22593215 ↗
• MalfunctionJul 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ELECTRODES WHERE THEY ARE SPLIT IN THE PACKAGE (UNOPENED) AND THEREFORE, ENCOUNTERS ISSUES DURING PROCEDURES, LIKE GETTING STUCK OR THE LOOP NOT COMING ALL THE WAY BACK IN. I WAS NOT NOTIFIED OF ANY PATIENT EVENTS ETC BUT HAD A SURGEON TELL ME THE LOOPS KEEP GETTING STUCK, WONT COMPLETE CUTS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. ACCORDING TO THE ISSUE DESCRIPTION THERE IS NO INDICATION THAT ANY PARTS HAVE DETACHED FROM THE ELECTRODES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470618 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING THE SURGEONS' CASE TODAY FOR A BLADDER TUMOR RESECTION WE USED THE BIPOLAR LOOP 0.3. ABOUT 3/4TH THE WAY THROUGH THE CASE THE LOOP BROKE. THE SURGEON WAS NOT VERY HAPPY ABOUT THIS AND SAID HE HAS NEVER HAD A LOOP BREAK BEFORE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289906 ↗
• InjuryJan 23, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE CUTTING LOOP EXPLODED DURING A CASE. ACCORDING TO THE INFORMATION RECEIVED, THE CONSEQUENCE OF THE EXPLOSION IS THAT THE BLADDER WAS CHARRED. THE SURGEON WAS NOT CONCERNED ABOUT ANY LONG-TERM HARM TO THE PATIENT. CROSS REFERENCE MDR: 9610617-2025-00048, 9610617-2025-00049, 9610617-2025-00050, 9610617-2025-00052, 9610617-2025-00053, 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222418 ↗
• InjuryJan 23, 2025Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED THAT THE CUTTING LOOP EXPLODED DURING A CASE. ACCORDING TO THE INFORMATION RECEIVED, THE CONSEQUENCE OF THE EXPLOSION IS THAT THE BLADDER WAS CHARRED. THE SURGEON WAS NOT CONCERNED ABOUT ANY LONG-TERM HARM TO THE PATIENT. CROSS REFERENCE MDR: 9610617-2025-00048, 9610617-2025-00049, 9610617-2025-00050, 9610617-2025-00052, 9610617-2025-00053, 9610617-2025-00054.

  Patient problems: Burn(s)

  MAUDE report 21222394 ↗
• MalfunctionAug 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A TRANSURETHRAL RESECTION PROSTATE PROCEDURE ON (B)(6) 2024, THE TIP BROKE OFF FROM CUTTING LOOP THE SURGON WAS ABLE TO RETRIEVE THE TIP. NO INJURIES WERE REPORTED TO THE PATIENT AND SURGON. HOWEVER, THE PROCEDURE HAD A 20 MINUTE DELAY HOWEVER, THE SURGON WAS ABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055190 ↗
• MalfunctionJul 28, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT LOOP BROKE OFF DURING PROCEDURE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421321 ↗
• MalfunctionJul 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BIPOLAR LOOP BROKE DURING THE CASE. THE PHYSICIAN RECOVERED ALL THE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410431 ↗
• MalfunctionJul 26, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOOP BROKE OFF AND THE STAFF HAD TO GO IN WITH A GRASPER AND PULL PIECES OUT. THERE WAS NO ADVERSE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402061 ↗
• InjuryJul 13, 2023Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THERE WAS A MALFUNCTION WITH A 27040GP130-S CUTTING LOOP, BIPOLAR 0.3MM, 24/26 FR. ACCORDING TO THE INFORMATION RECEIVED "THE BIPOLAR TOP BROKE OFF WHILE BEING USED IN THE BLADDER" PATIENT HARM IS NOT KNOWN AT THE DATE OF THIS REPORT. IT IS NOT KNOWN IF THE BROKEN PIECE REMAINED IN PATIENTS BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVES AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17319552 ↗
• MalfunctionJun 16, 2023Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THERE WAS A MALFUNCTION WITH A 27040GP130-S CUTTING LOOP, BIPOLAR 0.3MM, 24/26 FR. ACCORDING TO THE INFORMATION RECEIVED "THE BIPOLAR TOP BROKE OFF WHILE BEING USED IN THE BLADDER" PATIENT HARM IS NOT KNOWN AT THE DATE OF THIS REPORT. IT IS NOT KNOWN IF THE BROKEN PIECE REMAINED IN PATIENTS BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVES AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17148218 ↗
• MalfunctionOct 29, 2022Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4). PER SE ROBERT SAPP THE DOCTOR USED ONE OF THE ELECTRODES 27040GP130-S DOING A TURP PROCEDURE. THE WIRE LOOP PORTION BROKE OFF IN THE PATIENT. THEY SEARCHED FOR THE LOOP AND WERE UNABLE TO FIND THE LOOP. PER SE THE LOOP WAS NOT LOCATED DURING X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694788 ↗
• MalfunctionOct 28, 2022Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4). PER SE ROBERT SAPP THE DOCTOR USED ONE OF THE ELECTRODES 27040GP130-S DOING A TURP PROCEDURE. THE WIRE LOOP PORTION BROKE OFF IN THE PATIENT. THEY SEARCHED FOR THE LOOP AND WERE UNABLE TO FIND THE LOOP. PER SE THE LOOP WAS NOT LOCATED DURING X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690452 ↗
• MalfunctionSep 29, 2022Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4). SE EDWIN CARTY REPORTED THAT THE DOCTOR HAD 2 BIPOLAR LOOPS BREAK DURING SEPARATE PROCEDURES. THE LOOPS COMPLETELY CAME OFF THE TIP. NO PATIENT HARMED DURING THE PROCEDURE. BOTH LOOPS FROM THE SAME LOT. FIRST COMPLAINT IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508749 ↗
• MalfunctionJul 19, 2022Material Separation; Material Separation

  DURING A PROCEDURE, THE LOOP COMPLETELY CAME OFF THE TIP OF THE ELECTRODE. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053012 ↗
• MalfunctionDec 7, 2021Break

  TIP OF STORZ TURBT ELEMENT BROKE OFF IN PT. TWO BROKEN PIECES SEQUESTERED AND REMOVED FROM PT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12960785 ↗
• MalfunctionNov 26, 2020Overheating of Device; Overheating of Device

  ALLEGEDLY, DURING A UROLOGY PROCEDURE, TWO BIPOLAR ELECTRODE BROKE AND PIECES FELL INTO PATIENT. THE BROKEN PIECES WERE RETRIEVED, AND CUSTOMER CONFIRMED THERE WAS NO HARM TO PATIENT. THIS REPORT IS FOR THE FIRST ELECTRODE THAT BROKE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10909737 ↗
• MalfunctionNov 26, 2020Overheating of Device; Overheating of Device

  ALLEGEDLY, DURING A UROLOGY PROCEDURE, TWO BIPOLAR ELECTRODE BROKE AND PIECES FELL INTO PATIENT. THE BROKEN PIECES WERE RETRIEVED, AND CUSTOMER CONFIRMED THERE WAS NO HARM TO PATIENT. THIS REPORT IS FOR THE SECOND ELECTRODE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909705 ↗
• MalfunctionNov 20, 2020Material Separation; Material Separation

  ALLEGEDLY PER THE CUSTOMER, DURING A TURBT PROCEDURE, THE ELECTRODE BROKE OFF INSIDE THE PATIENT AND WAS SAFELY REMOVED. THE SECOND ELECTRODE ALSO BROKE OFF AND WAS SAFELY REMOVED WITH NO HARM TO THE PATIENT. THE ELECTRODE WAS REPLACED AND THE PROCEDURE COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879966 ↗
• MalfunctionNov 20, 2020Material Separation; Material Separation

  ALLEGEDLY PER THE CUSTOMER, DURING A TURBT PROCEDURE, THE ELECTRODE BROKE OFF INSIDE THE PATIENT. THE BROKEN PART OF THE ELECTRODE WAS SAFELY REMOVED WITH NO HARM TO THE PATIENT. THE ELECTRODE WAS REPLACED AND THE PROCEDURE COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10878411 ↗
• MalfunctionJan 22, 2020Material Separation; Material Separation

  ALLEGEDLY PER THE CUSTOMER, DURING A UROLOGY PROCEDURE, THE ELECTRODE BROKE OFF INSIDE THE PATIENT. THE BROKEN PART OF THE ELECTRODE WAS SAFELY REMOVED WITH NO HARM TO THE PATIENT. THE ELECTRODE WAS REPLACED AND THE PROCEDURE COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9616174 ↗