n.a. 27040XARecalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 04048551076521), received between Jun 21, 2017 and Aug 27, 2026 — classified as 33 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 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 102 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Break

  It was reported that broken ceramic tip fell inside patient during case and was removed by the surgeon. . It was reported that there was no delay and no negative impact in state of health.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484893 ↗
• InjuryAug 27, 2026Break

  It was reported that broken ceramic tip fell inside patient during case and was removed by the surgeon. . It was reported that there was no delay and no negative impact in state of health.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484887 ↗
• MalfunctionJul 21, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 25894937 ↗
• MalfunctionMay 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE INVOLVING THE USE OF A LASER, A SPONTANEOUS DETACHMENT OF THE CERAMIC COMPONENT OCCURRED, WITHOUT ANY UNUSUAL TECHNICAL MANEUVER. THE ANOMALY WAS DETECTED THROUGH THE ENDOSCOPIC IMAGE WHILE ADVANCING THROUGH THE URETHRA, OBSERVING AN IRREGULAR SEPARATION OF THE COMPONENTS. GIVEN THE RISK THAT THE PART COULD DETACH INSIDE THE BLADDER, THE MEDICAL PROFESSIONAL PROCEEDED WITH THE IMMEDIATE REMOVAL OF THE INSTRUMENT. THE ISSUE OCCURRED AT THE BEGINNING OF THE SURGICAL PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE PRODUCT, AND NO ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260417 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE THE CERAMIC TIP FROM THE INNER TUBE DETACHED FROM THE RESECTOSCOPE SHEATH AND WAS SUCCESSFULLY RETRIEVED USING STORZ BIOPSY FORCEPS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988239 ↗
• MalfunctionMar 19, 2026Material Fragmentation

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE WORKING ELEMENT CAME LOOSE. IT WAS NO LONGER USABLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644467 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, A 75 YEAR OLD PATIENT WAS HOSPITALIZED FOR A TRANSURETHRAL BLADDER RESECTION. DURING THE PROCEDURE, THE CERAMIC TIP OF THE INNER SHEATH OF THE CH26 RESECTOSCOPE BROKE OFF INSIDE THE PATIENT'S BLADDER (REF 27040XA/XC26040XA LOT IF). IT WAS REMOVED WITHOUT DIFFICULTY USING THE RESECTION LOOP. NO CONSEQUENCES. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573147 ↗
• MalfunctionFeb 26, 2026Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, A SHEATH MAY HAVE BROKEN DURING SURGERY INSIDE A PATIENT OR OUTSIDE DURING SET UP. THIS INCIDENT TOOK PLACE OVER TWO MONTHS AGO, THE EXACT DATE IS UNKNOWN. IT WAS CONFIRMED THAT THERE WAS NO HARM CAUSED TO THE PATIENT AND THAT THE BROKEN COMPONENTS OF THE SHEATH WERE ALL RETRIEVED AND DISPOSED OF. THERE WAS NO DELAY TO THE PATIENT'S TREATMENT, HOWEVER THE PROCEDURE MAY HAVE BEEN DELAYED IF THERE WAS AN X-RAY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461326 ↗
• InjuryJan 21, 2026Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, CERAMIC BEAK BROKE OFF WITHIN A PATIENT. THE BROKEN PIECE WAS REMOVED SUCCESSFULLY. A PROLONGATION OF 30MIN WAS REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137346 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, CERAMIC BEAK BROKE OFF WITHIN A PATIENT. THE BROKEN PIECE WAS REMOVED SUCCESSFULLY. A PROLONGATION OF 30MIN WAS REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137285 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BROKEN BEAK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123172 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BROKEN BEAK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123171 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BROKEN BEAK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123170 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BROKEN BEAK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123169 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, ELECTRODE BROKE AT THE END OF THE CASE. THEY CHANGED THE ELECTRODE AND FINISHED THE CASE. AFTER THE SET WAS CLEANED IN MDRD, IT WAS NOTED THAT THE SCOPE HAD BEEN DAMAGED. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23997062 ↗
• InjuryOct 15, 2025Device Reprocessing Problem; Detachment of Device or Device Component; Device Reprocessing Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP BROKE INSIDE PATIENT, AND A 2ND PROCEDURE WAS CARRIED OUT TO REMOVE.

  Patient problems: Insufficient Information

  MAUDE report 23303763 ↗
• InjurySep 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE INNER SHEATH BROKE INTO 2 PIECES JUST AFTER STARTING TO DIATHERMY INSIDE PATIENT BLADDER. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN CERAMIC TIP AFTER A LONG STRUGGLE. THE SURGERY WAS EXTENDED BETWEEN 30 AND 60 MINS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE SURGERY WAS COMPLETED BUT DELAYED FOR MORE THAN 30 MINS. THEREFORE THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089321 ↗
• InjurySep 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE INNER SHEATH BROKE INTO 2 PIECES JUST AFTER STARTING TO DIATHERMY INSIDE PATIENT BLADDER. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN CERAMIC TIP AFTER A LONG STRUGGLE. THE SURGERY WAS EXTENDED BETWEEN 30 AND 60 MINS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE SURGERY WAS COMPLETED BUT DELAYED FOR MORE THAN 30 MINS. THEREFORE THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089277 ↗
• InjurySep 4, 2025Material Fragmentation; Material Fragmentation

  DURING THE UROLOGICAL SURGERY, THE DISTAL CERAMIC PART OF THE SLEEVE BECAME DETACHED AND FELL INTO THE BLADDER. BECAUSE OF THIS, THE PROCEDURE TOOK LONGER THAN EXPECTED AND UNSCHEDULED INSTRUMENTS HAD TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974305 ↗
• InjurySep 4, 2025Break; Material Fragmentation; Break; Material Fragmentation

  DURING THE UROLOGICAL SURGERY, THE DISTAL CERAMIC PART OF THE SLEEVE BECAME DETACHED AND FELL INTO THE BLADDER. BECAUSE OF THIS, THE PROCEDURE TOOK LONGER THAN EXPECTED AND UNSCHEDULED INSTRUMENTS HAD TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974198 ↗
• MalfunctionJul 30, 2025Dent in Material; Detachment of Device or Device Component; Dent in Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLINIC THEY HAD A SHEATH, REFERENCE 27404XA, AND THE CERAMIC BAKELITE WAS DETACHED DURING SURGERY. THEY HAD TO FIND AN EXTRACTOR AND REMOVE IT. THEY WERE ABLE TO DO SO SUCCESSFULLY WITHOUT THE PATIENT BEING DAMAGED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666759 ↗
• MalfunctionJul 23, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE PRODUCT WAS DAMAGED. THE DAMAGE PART WAS RETRIEVED FROM INSIDE THE BODY. THE SURGERY, ORIGINALLY SCHEDULED TO TAKE ONE HOUR, ENDED TAKING THREE HOURS. DUE TO THE PROLONGATION ABOUT MORE THEN 60 MINUTES THE CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578475 ↗
• InjuryJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE PRODUCT WAS DAMAGED. THE DAMAGE PART WAS RETRIEVED FROM INSIDE THE BODY. THE SURGERY, ORIGINALLY SCHEDULED TO TAKE ONE HOUR, ENDED TAKING THREE HOURS. DUE TO THE PROLONGATION ABOUT MORE THEN 60 MINUTES THE CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578264 ↗
• MalfunctionJun 18, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN AQUABLATION CASE, THE CERAMIC TIP OF THE SHEATH BROKE OFF INSIDE THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287297 ↗
• InjuryJun 6, 2025Sparking; Noise, Audible; Unintended Electrical Shock; Sparking; Noise, Audible; Unintended Electrical Shock

  IT WAS REPORTED DURING A TURP PROCEDURE, AT SOME POINT A PIECE OF CERAMIC BROKE. A POST OP X-RAY WAS OBTAINED TO DETERMINE IF THE PIECE HAD FLUSHED OUT OR STAYED IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22159076 ↗