n.a. 27050CARecalls & reported problems
Karl Storz GmbH & Co. KG · Inner Sheath for 27050 SC · Class 2
Quick summary
This Karl Storz inner sheath for a cystourethroscope is a reusable scope component used in urological procedures. Most of the 60 reports describe the ceramic tip or other parts breaking off during a procedure, sometimes leaving fragments inside the patient that had to be removed with forceps, with a few reports of material separating, flaking or detaching. There were 22 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04048551077412), received between Mar 1, 2018 and Mar 12, 2026 — classified as 18 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Break” (28 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.
Reports received per month
Most reported problems
Device problems
- Break28
- Material Separation12
- Detachment of Device or Device Component10
- Material Fragmentation6
- Device Handling Problem3
- Fracture2
- Material Integrity Problem2
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Foreign Body In Patient12
- Insufficient Information10
- No Consequences Or Impact To Patient4
- Unspecified Kidney or Urinary Problem4
- Device Embedded In Tissue or Plaque2
- Erosion2
- Laceration(s)2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Break
IT WAS REPORTED THAT "DURING THE UROLOGICAL PROCEDURE, WHILE PENETRATING INTO THE BLADDER, THE CERAMIC TIP OF 27050CA BROKE AND PIECE OF IT GOT LOOSE UNDER THE PROSTATIC URETHRA. THE LOOSE PIECE HAD BEEN MANAGED TO PULL OUT BY GRASPING FORCEPS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. NEW INFORMATION RECEIVED ON MARCH 4, 2026: "ADVERSE CONSEQUENCES: PATIENT, MUCOSAL DAMAGE TO THE URETHRA" THE REPORTED DAMAGE TO THE URETHRAL MUCOSA CONSTITUTES INTERNAL TISSUE INJURY.
Patient problems: Erosion
MAUDE report 24577012 ↗MalfunctionFeb 20, 2026Loss of or Failure to Bond; Material Fragmentation
ACCORDING TO THE INFORMATION RECEIVED, WHEN THE INNER SHEATH WAS TAKEN OUTSIDE THE PATIENT, THE CERAMIC BEAK WAS SEEN TO BE BROKEN INTO TWO PARTS. BOTH PARTS WERE IDENTIFIED AND SENT FOR DECONTAMINATION. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405165 ↗InjuryFeb 12, 2026Break
NEW INFORMATION RECEIVED ON MARCH 4, 2026: "ADVERSE CONSEQUENCES: PATIENT, MUCOSAL DAMAGE TO THE URETHRA" THE REPORTED DAMAGE TO THE URETHRAL MUCOSA CONSTITUTES INTERNAL TISSUE INJURY.
Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions
MAUDE report 24328623 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT "CERAMIC BEAK OF THE INNER SHEATH BROKE OFF WHILST IN USE. DETACHED PART FELL INTO PATIENT. REPORTED THAT PART WAS RETRIEVED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858122 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT BAKELITE TIP IS DEFECTIVE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851342 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT DURING A UROLOGY OPERATION, THE CERAMIC INSULATION OF ARTICLE 27050CA WAS BROKEN AND SEPARATED. THE SURGEON IMMEDIATELY RETRIEVED AND COLLECTED THE SEPARATED FRAGMENT. A NEW REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770469 ↗MalfunctionDec 2, 2025Break; Break
THE FOLLOWING WAS REPORTED: "THE SHEATH BROKE OFF DURING A CASE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700364 ↗InjuryNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, THE INSTRUMENT WAS BEING USED WITH THE RELATIVE KIT TO PERFORM A TURP. DURING THE RESECTION THE SURGEON NOTICED THE INSULATED TIP HAD SHEARED OFF THE INSTRUMENT AND WAS FLOATING FREE IN THE PATIENT'S BLADDER. THE SURGEON EVENTUALLY MANAGE TO RETRIEVE THE BROKEN PART. THE PATIENT'S PROCEDURE COULD NOT BE CARRIED OUT AS PLANNED; NECESSARY BLOOD LOSS AND PROCEDURE TOOK LONGER THAN PLANNED. THE SURGEON SUFFERED THE STRESS OF TRYING TO EXTRACT THE BROKEN PART SAFELY WITHOUT CAUSING FURTHER TRAUMA TO THE PATIENT'S BLADDER. THE ANAESTHETIST WAS CONCERNED BECAUSE THE PATIENT HAD BEEN GIVEN A SPINAL ANAESTHETIC AND THE TIME FOR ITS EFFECTIVENESS WAS RUNNING OUT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 23618845 ↗InjuryNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED, THE INSTRUMENT WAS BEING USED WITH THE RELATIVE KIT TO PERFORM A TURP. DURING THE RESECTION THE SURGEON NOTICED THE INSULATED TIP HAD SHEARED OFF THE INSTRUMENT AND WAS FLOATING FREE IN THE PATIENT'S BLADDER. THE SURGEON EVENTUALLY MANAGE TO RETRIEVE THE BROKEN PART. THE PATIENT'S PROCEDURE COULD NOT BE CARRIED OUT AS PLANNED; NECESSARY BLOOD LOSS AND PROCEDURE TOOK LONGER THAN PLANNED. THE SURGEON SUFFERED THE STRESS OF TRYING TO EXTRACT THE BROKEN PART SAFELY WITHOUT CAUSING FURTHER TRAUMA TO THE PATIENT'S BLADDER. THE ANAESTHETIST WAS CONCERNED BECAUSE THE PATIENT HAD BEEN GIVEN A SPINAL ANAESTHETIC AND THE TIME FOR ITS EFFECTIVENESS WAS RUNNING OUT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 23618839 ↗InjuryOct 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT INCIDENT OF FRACTURES AT THE FRONT-END CERAMIC HEAD HAVE OCCURRED DURING HOSPITAL USE. A CERAMIC HEAD FROM A 27050CA DETACHED AND FELL INTO A PATIENT'S BLADDER, LEADING TO PROLONGED PROCEDURE TIME AND INCREASED PATIENT RISK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301215 ↗InjuryAug 28, 2025Break; Break
ACCORDING TO THE INFORMATION RECEIVED, DURING A PROCEDURE THE CERAMIC TIP BROKE WHILST IN A PATIENT. THE BLADDER WAS PUNCTURED. ALL PARTS OF TIP RECOVERED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: Laceration(s)
MAUDE report 22919821 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENDOSCOPIC UROLOGY PROCEDURE THE CERAMIC TIP BECAME DETACHED INSIDE THE PATIENT'S BLADDER. ONE PIECE WAS REMOVED FROM THE PATIENT AND SURGEONS WERE SATISFIED THAT THERE WAS NO FURTHER DEBRIS INSIDE THE PATIENT. ONE PIECE OF CERAMIC REMAINS INSIDE THE SHEATH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22721173 ↗InjuryJul 28, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PLASTIC PART OF THE RESECTOSCOPE SHEATH HAD SNAPPED OFF INSIDE THE PATIENT. IT WAS RETRIEVED IMMEDIATELY BUT A PART OF THE PLASTIC WAS STILL ATTACHED TO THE SHEATH. PROLONGED PROCEDURE FOR BLEEDING AFTER TURBT (RETURN TO THEATRE FROM RECOVERY). TOWARDS END OF PROCEDURE, THE BROKEN OFF RIM OF THE WHITE PLASTIC BEAK OF RESECTOSCOPE SEEN IN BLADDER. RETRIEVED CYSTOSCOPICALLY. DUE TO THE BLEEDING AND RETURN TO THEATRE FROM RECOVERY THE CASE IS DEEMED REPORTABLE
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 22634143 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT CERAMIC TIP BROKE OFF DURING THE PROCEDURE. THEY HAD TO OPEN ANOTHER TRAY AND DELAYED THE CASE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459879 ↗InjuryJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED CERAMIC RING BROKE OFF. THE SHAFT BROKE OFF WHILE THE PATIENT WAS BEING OPERATED ON. THE PIECE THAT BROKE OFF FELL INTO THE PATIENT. IT WAS DIFFICULT TO FIND DUE TO CLOTS BUT WAS EVENTUALLY REMOVED FROM THE BLADDER. THE PROCEDURE WAS THEN STOPPED, AND THE SHARP SHAFT WAS WITHDRAWN. THE PATIENT STILL NEEDS TO BE REASSESSED.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22322816 ↗InjuryJun 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE INFORMATION RECEIVED CERAMIC RING BROKE OFF. THE SHAFT BROKE OFF WHILE THE PATIENT WAS BEING OPERATED ON. THE PIECE THAT BROKE OFF FELL INTO THE PATIENT. IT WAS DIFFICULT TO FIND DUE TO CLOTS BUT WAS EVENTUALLY REMOVED FROM THE BLADDER. THE PROCEDURE WAS THEN STOPPED, AND THE SHARP SHAFT WAS WITHDRAWN. THE PATIENT STILL NEEDS TO BE REASSESSED.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22322815 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE INNER SLEEVE OF THE INSTRUMENT BROKE OFF INSIDE A PATIENT. THE PIECE COULD BE REMOVED WITHOUT COMPLICATION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115436 ↗InjuryMay 7, 2025Break; Break
ACCORDING TO THE INFORMATION RECEIVED, DURING A PROCEDURE THE CERAMIC TIP BROKE WHILST IN A PATIENT. THE BLADDER WAS PUNCTURED. ALL PARTS OF TIP RECOVERED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: Laceration(s)
MAUDE report 21978611 ↗MalfunctionFeb 21, 2025Break; Device Handling Problem; Break; Device Handling Problem
IT WAS REPORTED THAT: A TURBT PROCEDURE WAS DONE. ALL OFF A SUDDEN A PLASTIC PIECE WAS VISIBLE ON THE SCREEN INSIDE THE BLADDER, WHICH TURNED OUT TO BE A BROKEN PIECE OF THE RESECTOSCOPE INNER SHEET. WITH A BIOPSY GRASPER UROLOGY CONSULTANT EVENTUALLY MANAGED TO SAFELY REMOVE IT FROM THE PATIENT. NO INFORMATION ABOUT PATIENT INJURY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21438670 ↗MalfunctionFeb 21, 2025Break; Device Handling Problem; Break; Device Handling Problem
IT WAS REPORTED ON (B)(6) 2025, DURING A TURB PROCEDURE, THE CERAMIC BEAK OF SHEATH BROKE OFF OF INSTRUMENT INSIDE THE PATIENT AND NEEDED TO BE RETRIEVED WITH OTHER AVAILABLE INSTRUMENTATION. NO INFORMATION ABOUT PATIENT INJURY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21433593 ↗InjuryJan 16, 2025Break; Break
IT WAS REPORTED THAT CERAMIC BEAK HAD SMALL CHIP WITH PIECE MISSING UPON INSPECTION IN EP1 EQUIPMENT AUDIT. ISSUE WAS DETECTED AFTER PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. AS IT CANNOT BE EXCLUDED THAT THE MISSING PIECE WAS LOST IN THE PATIENT A REPORT IS REQUIRED PRECAUTIONARY.
Patient problems: Foreign Body In Patient
MAUDE report 21170533 ↗InjuryJan 16, 2025Break; Break
IT WAS REPORTED THAT CERAMIC BEAK HAD SMALL CHIP WITH PIECE MISSING UPON INSPECTION IN EP1 EQUIPMENT AUDIT. ISSUE WAS DETECTED AFTER PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. AS IT CANNOT BE EXCLUDED THAT THE MISSING PIECE WAS LOST IN THE PATIENT A REPORT IS REQUIRED PRECAUTIONARY.
Patient problems: Foreign Body In Patient
MAUDE report 21170523 ↗MalfunctionJan 8, 2025Break; Detachment of Device or Device Component; Device Handling Problem; Break; Detachment of Device or Device Component; Device Handling Problem
IT WAS REPORTED THAT A RESECTOSCOPE HAS BEING USED WITH GREEN LIGHT LASER VIA COMPATIBLE LASER WORKING INSERT 27050VL. THE SURGEON FIRED LASER WHILE INSIDE THE SHEATH RESULTING IN THE INNER SHEATH BREAKING OFF - THE CERAMIC BEAK BROKE OFF INSIDE. THE VISIBLE BROKEN PARTS WERE RETRIEVED. THE REMAINING BROKEN PARTS WERE EXPELLED VIA IRRIGATION. THE SURGEON AND TEAM WERE SATISFIED AS THERE WERE NO REMAINING PARTS IN PATIENT.THE SURGERY WAS PROLONGUED FOR LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFEREBCE MDR: 9610617-2025-00006.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103844 ↗MalfunctionOct 30, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER A CASE OF HOLMIUM LASER ENUCLEATION OF PROSTATE AND CYSTOLITHOTRIPSY, A CERAMIC TIP 0.9MM (L) AND 0.8MM (D) OF THE RESECTOSCOPE INNER SHEATH WAS FOUND BROKEN WITH MISSING PIECES DURING AN INSTRUMENT CHECK BEFORE BEING TRANSFERRED TO THE TSSU. A SEARCH OF THE ENVIRONMENT WAS CONDUCTED BUT IN VAIN. THE SURGEON WAS INFORMED AFTERWARD, A PELVIC X-RAY WAS PERFORMED AND NO OBVIOUS FOREIGN BODY FOUND. THE PATIENT WAS INFORMED BY THE SURGEON IN WARD.
Patient problems: Unintended Radiation Exposure
MAUDE report 20568819 ↗InjuryOct 30, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER A CASE OF HOLMIUM LASER ENUCLEATION OF PROSTATE AND CYSTOLITHOTRIPSY, A CERAMIC TIP 0.9MM (L) AND 0.8MM (D) OF THE RESECTOSCOPE INNER SHEATH WAS FOUND BROKEN WITH MISSING PIECES DURING AN INSTRUMENT CHECK BEFORE BEING TRANSFERRED TO THE TSSU. A SEARCH OF THE ENVIRONMENT WAS CONDUCTED BUT IN VAIN. THE SURGEON WAS INFORMED AFTERWARD, A PELVIC X-RAY WAS PERFORMED AND NO OBVIOUS FOREIGN BODY FOUND. THE PATIENT WAS INFORMED BY THE SURGEON IN WARD.
Patient problems: Unintended Radiation Exposure
MAUDE report 20568818 ↗
Other CYSTOURETHROSCOPE devices
- n.a. 11272C1Karl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall16 reports
- n.a. 11272VNUKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall4 reports
- C-VIEW 11272VUKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- C-VIEW 11272VKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- n.a. 11272CU1Karl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- C-VIEW 11272VUAKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- C-VIEW 11272VAKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- n.a. 11272VNKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.