n.a. 27050XARecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04048551078136), received between Apr 3, 2017 and Sep 21, 2026 — classified as 9 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  According to the information received, rotating broke in half where the water flows in. During a TURBT case on (b)(6), i got a call to bring another rotating resectoscope, upon entering was shown that the inner sheath broke. No injury was cause to the patient, case was delayed about 10 mins No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846385 ↗
• MalfunctionMay 12, 2026Material Fragmentation

  IT WAS REPORTED THAT THE INNER SHAFT WAS BROKEN. A SMALL FRAGMENT WAS FOUND IN THE PATIENT'S BLADDER AND SUBSEQUENTLY REMOVED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153411 ↗
• MalfunctionMar 20, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE ENDOSCOPE'S LENS WAS INFILTRATED, RESULTING IN A BLURRED FIELD OF VISION ON THE IMAGE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654318 ↗
• MalfunctionFeb 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY, THE CERAMIC HEAD OF THE OUTER SHEATH SHATTERED INSIDE THE PATIENT AND WAS COMPLETELY RETRIEVED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269145 ↗
• MalfunctionJan 20, 2026Fracture

  IT WAS REPORTED THAT "THE RESECTOSCOPE SHEATH OF THIS MODEL WAS PUT INTO USE AT THE HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, A FRACTURE OCCURRED AT THE HOLLOWED-OUT REAR END, AND FRAGMENTS FROM THE BREAKAGE ENTERED THE PATIENT'S BLADDER. THE SURGEON IMMEDIATELY USED GRASPING FORCEPS TO RETRIEVE THE FRAGMENTS. THE ENTIRE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114211 ↗
• MalfunctionJan 6, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT FRAGMENTS OF THE SHAFT WERE FOUND INSIDE THE PATIENT AFTER READMISSION FOR SURGERY. THIS HAPPENED UP TO FOUR MONTHS AFTER THE SUSPECTED FRACTURE. THE FRAGMENTS HAD REMAINED UNNOTICED IN THE PATIENT'S BODY SINCE THE ORIGINAL INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23973620 ↗
• InjuryJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT FRAGMENTS OF THE SHAFT WERE FOUND INSIDE THE PATIENT AFTER READMISSION FOR SURGERY. THIS HAPPENED UP TO FOUR MONTHS AFTER THE SUSPECTED FRACTURE. THE FRAGMENTS HAD REMAINED UNNOTICED IN THE PATIENT'S BODY SINCE THE ORIGINAL INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23970254 ↗
• MalfunctionDec 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE "ITEM IS BROKEN IN THE CERAMIC PART AT THE DISTAL END". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697985 ↗
• MalfunctionAug 28, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT "DURING THE TURP PROCEDURE VISION GOT TURBID AND THE BACKFLOW WAS NOT GOOD. IN SECONDS OF TIME THEY FOUND ONE METAL PIECE INSIDE THE PATIENT. AFTER THAT, WHILE CHECKING THE INSTRUMENT, IT WAS IDENTIFIED IT WAS FROM THE INNER SHEATH" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919581 ↗
• MalfunctionJul 25, 2025Mechanical Problem; Mechanical Problem

  ACCORDING TO THE INFORMATION RECEIVED, DISTAL CERAMIC INSULATOR BROKEN. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609456 ↗
• MalfunctionJul 23, 2025Break; Use of Device Problem; Detachment of Device or Device Component; Break; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A INNER SHEATH BROKE DURING PROCEDURE. THE CUSTOMER HAS REPORTED THAT THIS OCCURRED DURING THE PROCEDURE AND IT IS LIKELY THAT THE SURGEON BROKE THIS WHILST MANEUVERING THE SHEATH AND TELESCOPE. NO PART WAS FALLING IN THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579478 ↗
• InjuryJun 23, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT ACCORDING TO THE INITIAL INFORMATION, THE INSTRUMENT BROKE DURING SURGERY. ADDITIONAL INFORMATION RECEIVED ON JUNE 13,2025: DETAILED EVENT DESCRIPTION RECEIVED FROM KSE KOREA: "TOWARD THE END OF THE SURGERY, DURING PREPARATION FOR COAGULATION, CUTTING LOOP 011160-01 WAS BEING REPLACED WITH 011169-01.THE PROCEDURE INVOLVED DISCONNECTING A WORKING ELEMENT THAT WAS ASSEMBLED WITH 27050SL AND 27050XA. DURING THE DISCONNECTION PROCESS, THE ROTATING PART OF THE 27050XA (INNER SHEATH) WAS FOUND TO BE TORN. AS A RESULT, THE TIP OF THE CUTTING LOOP WAS CAUGHT IN THE SHEATH AND BROKE OFF, CAUSING DEVICE DAMAGE. TO EXAMINE THE SURGICAL SITE, THE ENDOSCOPE WAS REINSERTED, AND FRAGMENTS OF THE TORN SHEATH AND THE BROKEN TIP OF THE CUTTING LOOP WERE FOUND INSIDE THE BLADDER. DURING THE REMOVAL OF THESE FRAGMENTS, AN INJURY OCCURRED, RESULTING IN A BLADDER TEAR." IT WAS FURTHERMORE STATED THAT THE PATIENT WAS IMMEDIATELY TRANSFERRED (B)(6) HOSPITAL AND IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Laceration(s)

  MAUDE report 22311540 ↗
• MalfunctionJun 12, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ADDITIONAL INFORMATION: DETAILED EVENT DESCRIPTION RECEIVED FROM KSE KOREA: "TOWARD THE END OF THE SURGERY, DURING PREPARATION FOR COAGULATION, CUTTING LOOP 011160-01 WAS BEING REPLACED WITH 011169-01.THE PROCEDURE INVOLVED DISCONNECTING A WORKING ELEMENT THAT WAS ASSEMBLED WITH 27050SL AND 27050XA. DURING THE DISCONNECTION PROCESS, THE ROTATING PART OF THE 27050XA (INNER SHEATH) WAS FOUND TO BE TORN. AS A RESULT, THE TIP OF THE CUTTING LOOP WAS CAUGHT IN THE SHEATH AND BROKE OFF, CAUSING DEVICE DAMAGE. TO EXAMINE THE SURGICAL SITE, THE ENDOSCOPE WAS REINSERTED, AND FRAGMENTS OF THE TORN SHEATH AND THE BROKEN TIP OF THE CUTTING LOOP WERE FOUND INSIDE THE BLADDER. DURING THE REMOVAL OF THESE FRAGMENTS, AN INJURY OCCURRED, RESULTING IN A BLADDER TEAR." IT WAS FURTHERMORE STATED THAT THE PATIENT WAS IMMEDIATELY TRANSFERRED TO EUNPYUNG ST. MARY'S HOSPITAL AND IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Insufficient Information; Laceration(s)

  MAUDE report 22194817 ↗
• MalfunctionApr 28, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT FROM AN EXAMINATION, ABOUT TWO MONTHS AGO THERE WAS A RELATIVELY SIMILAR CASE WITH THE SAME CLIENT WITH INNER SHEATH 27050XA LOT RN07. IN THIS CASE, TOO, THERE WAS NO ADDITIONAL TIME FOR THE OPERATION, NO HARM WAS CAUSED TO THE PATIENT, AND THERE WAS NO CHANGE IN THE TREATMENT/HOSPITALIZATION PROTOCOL. IN THE REFERRED CASE (B)(4) IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE ITEM IS BROKEN, IN THE PROXIMAL SIDE THAT IS NEAR THE CONNECTION TO THE WORKING ELEMENT. HE REPLACED THE INNER SHEATH WITH A SIMILAR ITEM FROM ANOTHER AVAILABLE SET AND COMPLETED THE OPERATION. AT THE END OF THE OPERATION, THE BLADDER WAS EXAMINED AS PART OF THE OPERATION PROCESS, AND IT WAS OBSERVED TO BE CLEAN WITH NO EXTERNAL PARTS. THE SURGEON INFORMED US THAT THERE WAS NO ADDITIONAL TIME FOR THE OPERATION (EXCEPT FOR ABOUT A MINUTE TO REPLACE THE BROKEN COMPONENT). NO HARM WAS CAUSED TO THE PATIENT THERE WAS NO CHANGE IN THE TREATMENT/HOSPITALIZATION PROTOCOL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920004 ↗
• MalfunctionApr 28, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE ITEM IS BROKEN, IN THE PROXIMAL SIDE THAT IS NEAR THE CONNECTION TO THE WORKING ELEMENT. HE REPLACED THE INNER SHEATH WITH A SIMILAR ITEM FROM ANOTHER AVAILABLE SET AND COMPLETED THE OPERATION. AT THE END OF THE OPERATION, THE BLADDER WAS EXAMINED AS PART OF THE OPERATION PROCESS, AND IT WAS OBSERVED TO BE CLEAN WITH NO EXTERNAL PARTS. THE SURGEON INFORMED US THAT THERE WAS NO ADDITIONAL TIME FOR THE OPERATION (EXCEPT FOR ABOUT A MINUTE TO REPLACE THE BROKEN COMPONENT). NO HARM WAS CAUSED TO THE PATIENT THERE WAS NO CHANGE IN THE TREATMENT/HOSPITALIZATION PROTOCOL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919997 ↗
• InjuryApr 1, 2025Fracture; Material Fragmentation; Use of Device Problem; Fracture; Material Fragmentation; Use of Device Problem

  ACCORDING TO THE INFORMATION RECEIVED, A PART OF THE SHEATH DETACHED AND MIGRATED INTO THE PATIENT'S BLADDER DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21748824 ↗
• InjuryApr 1, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, A PART OF THE SHEATH DETACHED AND MIGRATED INTO THE PATIENT'S BLADDER DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21748822 ↗
• MalfunctionMar 28, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT PART OF THE BROWN PLASTIC BROKE AND FELL INTO THE PATIENT. THIS WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 15 MINUTES. NO ADDITIONAL INTERVENTION WAS REQUIRED AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720045 ↗
• MalfunctionMar 21, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE OFF DURING USE. THE SURGEON WAS ABLE TO END THE SURGERY IN A NORMAL WAY, WITHOUT ANY DELAY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664277 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED DURING A TURP BIOPSY PROCEDURE ON (B)(6) 2024, THERE WAS A BREAKAGE OF THE CERAMIC. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED, THE DOCTOR WAS ABLE TO REMOVE THE BROKEN PIECE FLOATING AROUND AND THERE WAS A SURGAL DELAY OF APPROXIMATELY 25 MINUTES WHILE ATTEMPTING TO REMOVE THE BROKEN PIECES. HOWEVER, IT WAS REPORTED THAT IT'S HARD TO TELL IF THE BROKEN PIECE MAY HAVE CUT THE PATIENT ON THE WAY OUT.

  Patient problems: Insufficient Information

  MAUDE report 21092139 ↗
• InjuryNov 27, 2024Break; Break

  IT WAS REPORTED THAT A PIECE OF A CERAMIC BEAK WAS FOUND AND REMOVED FROM PATIENT'S BLADDER IN (B)(6) 2024. IT HAS BEEN ADVISED THAT THE INITIAL PROCEDURE WAS IN 2019. PATIENT HAD EXPERIENCED INFECTIONS AND PAIN POST OP 2019.

  Patient problems: Discomfort; Foreign Body In Patient

  MAUDE report 20800940 ↗
• InjuryNov 27, 2024Break; Break

  IT WAS REPORTED THAT A PIECE OF A CERAMIC BEAK WAS FOUND AND REMOVED FROM PATIENT'S BLADDER IN (B)(6) 2024. IT HAS BEEN ADVISED THAT THE INITIAL PROCEDURE WAS IN 2019. PATIENT HAD EXPERIENCED INFECTIONS AND PAIN POST OP 2019.

  Patient problems: Discomfort; Foreign Body In Patient

  MAUDE report 20800927 ↗
• MalfunctionNov 12, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INNER SHEATH BAYONET IS EASY TO BREAK IN THE PROCESS OF USE, AND THE SUBSEQUENT OPERATION CANNOT BE CARRIED OUT NORMALLY. NO ADVERSE CONSEQUENCES. HOSPITAL INSPECTION FOUND THAT THE INTERNAL SHEATH BAYONET WAS EASY TO BREAK DURING USE, RESULTING IN MORE PRODUCT OBSOLETION, SUBSEQUENT OPERATIONS COULD NOT BE CARRIED OUT NORMALLY, BUT DID NOT CAUSE ANY HUMAN INJURY AND ADVERSE EVENTS. CROSS REFERENCE MDR: 9610617-2024-00440.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668145 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THE INNER SHEATH BAYONET IS EASY TO BREAK IN THE PROCESS OF USE, AND THE HOSPITAL IS DAMAGED MORE, AND THE SUBSEQUENT OPERATION CANNOT BE CARRIED OUT NORMALLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668131 ↗
• MalfunctionNov 12, 2024Break; Optical Obstruction; Break; Optical Obstruction

  IT WAS REPORTED THAT THE INNER SHEATH BAYONET IS EASY TO BREAK IN THE PROCESS OF USE, AND THE SUBSEQUENT OPERATION CANNOT BE CARRIED OUT NORMALLY. NO ADVERSE CONSEQUENCES. HOSPITAL INSPECTION FOUND THAT THE INTERNAL SHEATH BAYONET WAS EASY TO BREAK DURING USE, RESULTING IN MORE PRODUCT OBSOLETION, SUBSEQUENT OPERATIONS COULD NOT BE CARRIED OUT NORMALLY, BUT DID NOT CAUSE ANY HUMAN INJURY AND ADVERSE EVENTS. CROSS REFERENCE MDR: 9610617-2024-00439.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666058 ↗