n.a. 27040GP1-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04048551393482), received between Apr 3, 2017 and May 4, 2026 — classified as 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED: THE DEVICE SPLIT IN HALF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073671 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT THE SURGEON WAS USING OUR 27040GP1-S BIPOLAR LOOP FOR A TURP PROCEDURE AND 30 MINUTES INTO THE CASE THE LOOP CAME APART AND BASICALLY SPLIT IN HALF. THE LOOP WAS BRAND NEW RIGHT OUT OF THE STERILE PACKAGING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CONCOMITANT DEVICE FILED UNDER INTERNAL COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570650 ↗
• MalfunctionMay 6, 2025Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE USING UH400U AND 27040GP1-S, THE PATIENT WAS BURNED. THE UH400U TURN ON ITS OWN NO PETAL WAS STEPPED ON AND IT WAS POSSIBLE IT WAS ON THE WRONG SETTING. CROSS REFERENCE MEDWATCH 9610617-2025-00803.

  Patient problems: Burn(s)

  MAUDE report 21971369 ↗
• InjuryMay 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE USING UF400 AND 27040FP1-S THE PATIENT WAS BURNED. THE UF400 TURN ON IT'S OWN NO PETAL WAS STEPPED ON AND IT WAS POSSIBLE IT WAS ON THE WRONG SETTING. CROSS REFERENCE MEDWATCH 9610617-2025-00803.

  Patient problems: Burn(s)

  MAUDE report 21971331 ↗
• InjuryMay 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE USING UF400 AND 27040FP1-S THE PATIENT WAS BURNED. THE UF400 TURN ON IT'S OWN NO PETAL WAS STEPPED ON AND IT WAS POSSIBLE IT WAS ON THE WRONG SETTING. CROSS REFERENCE MEDWATCH 9610617-2025-00804.

  Patient problems: Burn(s)

  MAUDE report 21971315 ↗
• MalfunctionMay 6, 2025Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE USING UH400U AND 27040GP1-S, THE PATIENT WAS BURNED. THE UH400U TURN ON ITS OWN NO PETAL WAS STEPPED ON AND IT WAS POSSIBLE IT WAS ON THE WRONG SETTING. CROSS REFERENCE MEDWATCH 9610617-2025-00804.

  Patient problems: Burn(s)

  MAUDE report 21971303 ↗
• InjuryFeb 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT WAS IN FOR TRANSURETHRAL BLADDER TUMOR RESECTION. IN THE COMMISSION OF THE PLANNED PROCEDURE ON (B)(6) 2025, A RESECTOSCOPE LOOP ELECTRODE BECAME CAUGHT BY THE EDGE OF THE RESECTOSCOPE CANNULA, CAUSING THE LOOPED WIRE TO COME APART. THE RESECTOSCOPE WAS WITHDRAWN, THE LOOP ELECTRODE FRAGMENT WAS RETRIEVED IN ITS ENTIRETY. THE PIECES OF THE LOOP ELECTRODE WERE EXAMINED BY THE CIRCULATING RN'S, SURGICAL TECH AND THE SURGEON AND ALL AGREED THAT THE ELECTRODE WAS REMOVED FROM THE PATIENT COMPLETELY. THE SURGEON COMPLETED A REVIEW OF THE BLADDER CYSTOSCOPICALLY AND FOUND NO RETAINED PIECES. ALL RELATED EQUIPMENT (THE RESECTOSCOPE, THE IGLESIAS WORKING ELEMENT AND THE RESECTOSCOPE ELECTRODE) WERE REVIEWED PREOPERATIVELY WITH NO DEFECTS NOTED PREOPERATIVELY. RESECTOSCOPIC ELECTRODE ACCIDENTLY PULLED APART UPON REMOVAL FROM THE RESECTOSCOPIC CANNULA, ALL PIECES REMOVED. PATIENT EXAMINED IMMEDIATELY AFTER RETRIEVAL OF THE BROKEN ELECTRODE BY SURGEON USING VIDEOSCOPIC CYSTOSCOPE AND NO INJURY WAS FOUND. THE ELECTRODE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318170 ↗
• InjuryFeb 5, 2025Break; Arcing; Break; Arcing

  IT WAS REPORTED THAT A PATIENT WAS IN FOR TRANSURETHRAL BLADDER TUMOR RESECTION. IN THE COMMISSION OF THE PLANNED PROCEDURE ON (B)(6) 2025, A RESECTOSCOPE LOOP ELECTRODE BECAME CAUGHT BY THE EDGE OF THE RESECTOSCOPE CANNULA, CAUSING THE LOOPED WIRE TO COME APART. THE RESECTOSCOPE WAS WITHDRAWN, THE LOOP ELECTRODE FRAGMENT WAS RETRIEVED IN ITS ENTIRETY. THE PIECES OF THE LOOP ELECTRODE WERE EXAMINED BY THE CIRCULATING RN'S, SURGICAL TECH AND THE SURGEON AND ALL AGREED THAT THE ELECTRODE WAS REMOVED FROM THE PATIENT COMPLETELY. THE SURGEON COMPLETED A REVIEW OF THE BLADDER CYSTOSCOPICALLY AND FOUND NO RETAINED PIECES. ALL RELATED EQUIPMENT (THE RESECTOSCOPE, THE IGLESIAS WORKING ELEMENT AND THE RESECTOSCOPE ELECTRODE) WERE REVIEWED PREOPERATIVELY WITH NO DEFECTS NOTED PREOPERATIVELY. RESECTOSCOPIC ELECTRODE ACCIDENTLY PULLED APART UPON REMOVAL FROM THE RESECTOSCOPIC CANNULA, ALL PIECES REMOVED. PATIENT EXAMINED IMMEDIATELY AFTER RETRIEVAL OF THE BROKEN ELECTRODE BY SURGEON USING VIDEOSCOPIC CYSTOSCOPE AND NO INJURY WAS FOUND. THE ELECTRODE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318168 ↗
• MalfunctionNov 14, 2024Low Audible Alarm; Break; Fracture; Detachment of Device or Device Component; Low Audible Alarm; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED DURING A MEDICAL PROCEDURE, THE CUTTING LOOP ONE WHOLE YELLOW SIDE AND THE LOOP HAD COME OFF AND WAS IN THE BLADDER. THE SURGEON USED THE BALL TO FINISH THE REST OF THE CASE. NO HARM WAS CAUSED TO THE PATIENT.

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

  MAUDE report 20689472 ↗
• MalfunctionNov 14, 2024Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED DURING A MEDICAL PROCEDURE, THE SECOND CUTTING LOOP STARTED BENDING AFTER USING FOR A WHILE, WHEN WE PULLED IT OUT, THE LOOP FELL OFF. WE THEN USED THE BALL TO FINISH THE REST OF THE CASE. NO HARM WAS CAUSED TO THE PATIENT.

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

  MAUDE report 20689250 ↗
• MalfunctionAug 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A TURP PROCEDURE ON (B)(6) 2024, THE CUTTING LOOP, BIPOLAR, 24/26 FR BROKE OFF INSIDE THE PATIENT. HOWEVER, THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN LOOP END. NO HARM TO THE PATIENT WAS NOTED AND NO SURGICAL DELAY WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924047 ↗
• MalfunctionJun 6, 2024Use of Device Problem; Sparking; Use of Device Problem; Sparking

  IT WAS REPORTED THAT DURING TUPR CASE ON (B)(6) 2024, THE BIPOLAR CUTTING LOOP THAT WAS ATTACHED TO THE BIPOLAR CABLE SPARKED/BURNED DURING THE CASE. THERE WAS NO REPORT OF PATIENT NOR USER INJURY, AND THEY WERE ABLE TO COMPLETE THE CASE USING A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477863 ↗
• MalfunctionOct 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PARTS OF THE DEVICE BROKE OFF IN THE PATIENT'S BODY DURING THE PROCEDURE. THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES AND NO PATIENT HARM IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992722 ↗
• MalfunctionOct 19, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PARTS OF THE DEVICE BROKE OFF DURING PROCEDURE. THE SURGEON RETRIEVED ALL PIECES AND NO PATIENT HARM IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970224 ↗
• InjuryJul 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PHYSICIAN WAS USING THE ORIGINAL DESIGNED BIPOLAR LOOPS, BUT SWITCHED TO MONOPOLAR AS THE BIPOLAR LOOPS WERE TOO FRAGILE. SHE HAS RECENTLY TRIED THE NEW DESIGNED BIPOLAR LOOP, WHICH HAS THE ADDITIONAL SMALL, NEUTRAL LOOP ON THE OPPOSITE END. THIS NEUTRAL LOOP SHOULD NOT GET HEATED, BUT IN HER CASE IT DID AND BURNED TISSUE IN A LOCATION THAT WAS NOT INTENDED.

  Patient problems: Burn(s)

  MAUDE report 17401477 ↗
• InjuryJul 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PHYSICIAN WAS USING THE ORIGINAL DESIGNED BIPOLAR LOOPS, BUT SWITCHED TO MONOPOLAR AS THE BIPOLAR LOOPS WERE TOO FRAGILE. SHE HAS RECENTLY TRIED THE NEW DESIGNED BIPOLAR LOOP, WHICH HAS THE ADDITIONAL SMALL, NEUTRAL LOOP ON THE OPPOSITE END. THIS NEUTRAL LOOP SHOULD NOT GET HEATED, BUT IN HER CASE IT DID AND BURNED TISSUE IN A LOCATION THAT WAS NOT INTENDED.

  Patient problems: Burn(s)

  MAUDE report 17401476 ↗
• MalfunctionApr 19, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION WE RECEIVED, THE ELECTRODE ITEM 27040GP1-S BIPOLAR CUTTING LOOP WAS MISSING FROM THE ELECTRODE. THE LOOP WAS FOUND INSIDE THE PATIENT'S BLADDER, IT WAS RETRIEVED AND THE TURP PROCEDURE COMPLETED WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768903 ↗
• MalfunctionDec 21, 2022Material Fragmentation; Material Frayed; Arcing of Electrodes; Sparking; Material Fragmentation; Material Frayed; Arcing of Electrodes; Sparking

  ACCORDING TO THE INFORMATION RECEIVED DURING THE CASE, USING THE RESECTOSCOPE DURING HYSTEROSCOPY, THE BIPOLAR CUTTING LOOP STARTED TO FRAY, MELT, AND CREATED A SPARK. NO CHANGE TO PATIENTS' STATUS AND DIDN'T CAUSE ANY FURTHER COMPLICATIONS DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022330 ↗
• MalfunctionOct 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTERO RESECTION, THE LOOP BROKE 3 CM FROM ITS END AS WELL AS THE WIRE. THE RUPTURED PART REMAINED IN THE ENDOMETRIUM AND REQUIRED REMOVAL WITH HYSTEROSCOPE FORCEPS. NO CONFIRMATION OF INJURY OR ANY ADVERSE IMPACT TO THE PATIENT, USER OR THIRD PARTY REPORTED. THE BROKEN PART WAS RETRIEVED WITH HYSTEROSCOPE FORCEPS. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695112 ↗
• MalfunctionOct 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HYSTERO RESECTION, THE LOOP BROKE 3 CM FROM ITS END AS WELL AS THE WIRE. THE RUPTURED PART REMAINED IN THE ENDOMETRIUM AND REQUIRED REMOVAL WITH HYSTEROSCOPE FORCEPS. NO CONFIRMATION OF INJURY OR ANY ADVERSE IMPACT TO THE PATIENT, USER OR THIRD PARTY REPORTED. THE BROKEN PART WAS RETRIEVED WITH HYSTEROSCOPE FORCEPS. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693894 ↗
• MalfunctionSep 30, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER'S COMPLAINT REFERENCE NUMBER FOR THIS CASE IS (B)(4). ACCORDING TO THE INFORMATION RECEIVED A BIPOLAR ELECTRODE BROKE DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO INJURY TO PATIENT, USER OR THIRD DUE TO THIS MALFUNCTION. ALL PARTS WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519149 ↗
• MalfunctionJul 14, 2022Break; Break

  THE ELECTRODE BROKE DURING A PROCEDURE, AND THE CUSTOMER BELIEVES THAT A PIECE BROKE OFF INTO THE PATIENT AND HAD TO BE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15020462 ↗
• MalfunctionNov 23, 2021Break; Material Fragmentation; Break; Material Fragmentation

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): INITIALLY RECEIVED INFORMATION: "RESECTION WITH BIPOLAR LOOP OF TRILOBED PROSTATIC ADENOMA. EXTRACTING THE LOOP WE FIND THE LACK OF THE BIPOLAR LOOP. HEMOSTASIS OF THE LODGE. PROSTATIC BED. AFTER NUMEROUS UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE LOOP SECTION, BECAUSE OF POOR VISIBILITY DUE TO LOW BLEEDING, IT WAS DECIDED TO STOP THE PROCEDURE..." "INCIDENT CONSEQUENCE: SPECIFIC MEDICAL INTERVENTION." FURTHER INFORMATION RECEIVED: "-ON (B)(6) THE PATIENT UNDERWENT A FLEXIBLE URETHROCYSTOSCOPY FOR A SCHEDULED CHECK-UP (HOWEVER, IN CONDITIONS OF ABSOLUTE WELL-BEING, NO FEVER, NO DYSURIA, NO HAEMATURIA). DURING THE INVESTIGATION, THE FRAGMENT OF A BIPOLAR RESECTION LOOP THAT HAD "BROKEN OFF" DURING SURGERY ON (B)(6) 2021 WAS FOUND AT THE BULBAR URETHRA. THIS FRAGMENT WAS EXTRACTED COMPLETELY. SUBSEQUENT URETHRAL AND BLADDER INSPECTION DID NOT DOCUMENT ANY OTHER FRAGMENTS. THE PATIENT WAS INFORMED ABOUT THE REMOVAL OF THE FRAGMENT. A FOLLOW-UP VISIT HAS BEEN SCHEDULED IN ABOUT 2 WEEKS." (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12861532 ↗
• InjuryMay 21, 2021Break; Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): AS REPORTED: "DURING AN ENDOSCOPE VENTRICULOSCOPY, USE OF A 28161 SF COAGULANT FORCEPS THAT MAY HAVE ENTERED THE WORKING CHANNEL OF THE ENDOSCOPE BUT THE END OF WHICH BROKE DURING REMOVAL. THIS EXTREMITY WAS IMPOSSIBLE TO RECOVER BECAUSE IT WAS INACCESSIBLE BY THE LATERAL VENTRICLE. OBLIGATION TO CONVERT TO OPEN SURGERY AND RETRY AND FAILURE TO RECOVER MATERIAL."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11863542 ↗
• InjuryMay 21, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): ON (B)(6) 2021, DURING A SURGICAL INTERVENTION, THE BIPOLAR RESECTION LOOP AGAIN SEPARATED AT THE LEVEL OF THE YELLOW FIXATION SYSTEMS. THE MATERIAL IS LOST BETWEEN THE BLADDER AND THE URETHRA WITH RISKS OF PERFORATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11863538 ↗