n.a. 27040GP140-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04048551393208), received between May 18, 2022 and Jul 10, 2025 — classified as 15 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 22470624 ↗
• MalfunctionMar 12, 2025Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED DURING A TURP PROCEDURE ON (B)(6) 2025 THE CUTTING LOOP KEEPS GETTING STUCK, THE SURGEON CAN'T COMPLETE A CUT BECAUSE THE LOOP WON'T GO BACK IN. THE SURGEON HAS TO PULL OUT THE SCOPE BECAUSE IT GETS STUCK IN THE SHEATH SO WHEN HE PULLS THE SCOPE OUT TO GIVE IT MORE ROOM TO GET IT OUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586121 ↗
• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A TURBT PROCEDURE ON (B)(6) 2024, THE LOOP SPLIT. NO DIRECT PATIENT INJURY WAS REPORTED. THEY WERE ABLE TO COMPLETE THE PROCEDURE USING ANOTHER DEVICE. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20630397 ↗
• MalfunctionSep 27, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED DURING A MEDICAL PROCEDURE (DATE OF THE PROCEDURE WAS NOT PROVIDED), THE CUTTING LOOP, BIPOLAR WER3E CATCHING ON THE TIP OF THE SHEATHS WHICH CAUSES THE LOOP TO BE UNABLE TO RETRACT BACK INTO THE SHEATH AND THEN THE LOOP BREAKS OFF. HOWEVER, NO INJURIES WERE REPORTED AND NO SERGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322509 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED DURING AN ENUCLEATION OF PROSTATE ON (B)(6)2024, THE LOOP BROKE INSIDE OF THE PATIENT. AN EXTENSIVE CHECK OF THE PATIENT'S BLADDER WAS COMPLETED TO ENSURE THERE WAS NO INJURY OR RETAINED FOREIGN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251941 ↗
• MalfunctionJul 11, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE NOT PROVIDED), THE CUTTING LOOP STARTED CATCHING ON THE TIP OF THE SHEATH. EVENTUALLY THE LOOP WAS UNABLE TO BE RETRACTED BACK INTO THE SHEATH, AND THEN BROKEN OFF INTO THE PATIENT AS A RESULT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726469 ↗
• MalfunctionJul 11, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE NOT PROVIDED), THE CUTTING LOOP STARTED CATCHING ON THE TIP OF THE SHEATH. EVENTUALLY THE LOOP WAS UNABLE TO BE RETRACTED BACK INTO THE SHEATH, AND THEN BROKEN OFF INTO THE PATIENT AS A RESULT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726387 ↗
• MalfunctionJul 11, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE (CASE TYPE AND DATE NOT PROVIDED), THE CUTTING LOOP STARTED CATCHING ON THE TIP OF THE SHEATH. EVENTUALLY THE LOOP WAS UNABLE TO BE RETRACTED BACK INTO THE SHEATH, AND THEN BROKEN OFF INTO THE PATIENT AS A RESULT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726367 ↗
• MalfunctionMay 14, 2024

  SURGEON WAS OPERATING DURING AN ENUCLEATION OF PROSTATE WHEN THE LOOP BROKE INSIDE OF THE PATIENT. THE BROKEN LOOP RESECTOR WAS REMOVED FROM THE PATIENT'S BLADDER. A SMALL PIECE OF THE INSTRUMENT WAS UNABLE TO BE COLLECTED AS THE SURGEON VISUALIZED THE PIECE GOING IN TO THE SUCTION COLLECTION. AN EXTENSIVE CHECK OF THE PATIENT'S BLADDER WAS COMPLETED TO ENSURE THERE WAS NO INJURY OR RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19310266 ↗
• MalfunctionMar 15, 2024Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE BIPOLAR CUTTING LOOP BROKE DURING PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18916442 ↗
• MalfunctionJun 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WAS EVENT WITH 27040GP140-S CUTTING LOOP, BIPOLAR 24/26 FR. ACCORDING TO THE INFORMATION RECEIVED FROM THE SALESREP: ACCORDING TO THE FACILITY THE ITEM BROKE OFF DURING THE PROCEDURE AND INTO THE PATIENTS BLADDER. PATIENT HARM WAS NOT NOTED AT TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17070536 ↗
• MalfunctionFeb 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WAS EVENT WITH 27040GP140-S CUTTING LOOP, BIPOLAR 24/26 FR. ACCORDING TO THE INFORMATION RECEIVED VIA MEDWATCH REPORT (B)(4): THE SURGEON WAS PERFORMING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND USED THE STORZ BIPOLAR CUTTING LOOP, (DIAMETER 0.40MM). THE PRODUCT WAS DEFECTIVE. THE TOP PRONGS ON THE DEVICE CAME OFF IN THE PATIENT'S URETHRA. THE SURGEON WAS ABLE TO REMOVE THE PIECES AND APPLIED A 22 FR 3 WAY FOLEY CATHETER FOR HEMATURIA. PATIENT HARM WAS NOT NOTED AT TIME OF THIS REPORT AS THE CATHETER WAS INSERTED FOR PREVENTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 16335626 ↗
• MalfunctionJan 17, 2023Defective Device; Detachment of Device or Device Component

  THE SURGEON WAS PERFORMING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND USED THE STORZ BIPOLAR CUTTING LOOP, (DIAMETER 0.40MM). THE PRODUCT WAS DEFECTIVE. THE TOP PRONGS ON THE DEVICE CAME OFF IN THE PATIENT'S URETHRA. THE SURGEON WAS ABLE TO REMOVE THE PIECES AND APPLIED A 22 FR 3 WAY FOLEY CATHETER FOR HEMATURIA. MANUFACTURER RESPONSE FOR ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL, N.A. (PER SITE REPORTER). DEVICE WAS COLLECTED BY THE REPRESENTATIVE.

  Patient problems: Hematuria

  MAUDE report 16183402 ↗
• MalfunctionJul 1, 2022Break; Material Separation; Break; Material Separation

  DURING A TURP, 90 MINUTES INTO THE PROCEDURE THE DOCTOR NOTICED THE LOOP THINNING, AT WHICH TIME THE LOOP BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED WITH NO HARM TO PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885757 ↗
• MalfunctionMay 18, 2022Break; Material Separation; Break; Material Separation

  DURING A TURP, THE PROXIMAL END OF THE LOOP BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED WITH NO HARM TO PATIENT. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427180 ↗