n.a. 26050CARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551007228), received between Sep 1, 2023 and Sep 28, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Electrical Shorting

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924034 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017291 ↗
• InjuryJul 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE SURGEON OBSERVED THAT THE CERAMIC TIP OF THE INNER SHEATH OF THE RESECTOSCOPE HAD DETACHED AND WAS LOCATED IN THE BLADDER. DUE TO SIGNIFICANT URETHRAL STENOSIS, EXTRACTION VIA THE NATURAL ROUTE PROVED IMPOSSIBLE. AN ATTEMPT WAS MADE TO FRAGMENT IT USING A 30W HOLMIUM LASER, ALLOWING PARTIAL EXTRACTION OF A FRAGMENT; HOWEVER, A RESIDUAL FRAGMENT REMAINED IN PLACE, INACCESSIBLE VIA THE TRANSURETHRAL ROUTE. ADDITIONALLY, PERFORATION OF THE URETHRAL WALL BY THE CERAMIC TIP LED TO SIGNIFICANT EXTRAVASATION OF SALINE INTO THE RETROPERITONEUM, EVIDENCED BY A DISCREPANCY BETWEEN THE IRRIGATED VOLUME AND THE ASPIRATED VOLUME. GIVEN THE IMPOSSIBILITY OF EXTRACTING THE REMAINING FRAGMENT ENDOSCOPICALLY, THE DECISION WAS MADE TO CONVERT TO LAPAROSCOPY. HOWEVER, EXTRACTION PROVED PARTICULARLY DIFFICULT DUE TO THE RETROVESICAL LOCATION OF THE FRAGMENT. THE PATIENT HAD TO BE TRANSFERRED TO INTENSIVE CARE AFTER EXTRACTION OF THE REMAINING FRAGMENT.

  Patient problems: Insufficient Information; Internal Organ Perforation; Urethral Stenosis/Stricture

  MAUDE report 25782708 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SHEATH CERAMIC BROKE WHILST IN USE ON PATIENT, DEBRIS REMOVED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280740 ↗
• MalfunctionJun 26, 2025Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  THE CUSTOMER DID NOT PROVIDE ANY ERROR DESCRIPTION. DURING INITIAL EVALUATION OF THE PRODUCT (26050CA INNER SHEATH FOR RESECTOSCOPE) IT WAS FOUND THAT THERE IS A LOOSE ADHESIVE BOND AT THE CERAMIC BEAK AND THE BEAK HAS COME OFF FROM THE SHEATH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340759 ↗
• InjuryJan 31, 2025Leak/Splash; Unintended Electrical Shock; Leak/Splash; Unintended Electrical Shock

  IT WAS REPORTED THAT LEAKAGE OCCURRED FOR THE THIRD TIME IN THE USE OF ELECTRIC ENDOSCOPIC INSTRUMENTS IN THE OPERATION BY USER, AND SHOCKED THE PATIENT, BUT ONLY CONVULSED DURING THE OPERATION, CAUSING NO SERIOUS INJURY, AND THERE WAS NO INTERVENTION TREATMENT IN THE LATER STAGE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER IMPACT OR CONSEQUENCES. HOWEVER, DUE TO THE REPORTED SHOCK AND CONVULSION OF THE PATIENT THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 21287065 ↗
• InjuryJan 31, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT LEAKAGE OCCURRED FOR THE THIRD TIME IN THE USE OF ELECTRIC ENDOSCOPIC INSTRUMENTS IN THE OPERATION BY USER, AND SHOCKED THE PATIENT, BUT ONLY CONVULSED DURING THE OPERATION, CAUSING NO SERIOUS INJURY, AND THERE WAS NO INTERVENTION TREATMENT IN THE LATER STAGE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO FURTHER IMPACT OR CONSEQUENCES. HOWEVER, DUE TO THE REPORTED SHOCK AND CONVULSION OF THE PATIENT THIS CASE IS DEEMED REPORTABLE FOR PRECAUTIONARY REASONS.

  Patient problems: Convulsion/Seizure; Electric Shock

  MAUDE report 21287062 ↗
• InjurySep 1, 2023Material Separation; Device Handling Problem; Material Separation; Device Handling Problem

  IT WAS REPORTED THAT DURING A LASER AURIGA 30 FRAGMENTATION OF A LARGE BLADDER STONE WITH THE STORZ RESECTOR, THE CERAMIC TIP BROKE OFF AND PASSED INTO THE BLADDER. THIS FORCED THE SURGEON TO DO A LAPAROTOMY TO RECOVER THE PART INSIDE THE LAVA. THE CERAMIC COMPLETELY SEPARATED FROM THE SHEATH AND PASSED INTO THE BLADDER. THE SURGERY WAS PROLONGED FOR 1H 30 MINUTES. THE RESECTION OF THE PROSTATE WAS RESCHEDULED 15 DAYS LATER.

  Patient problems: Insufficient Information

  MAUDE report 17671662 ↗
• InjurySep 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LASER AURIGA 30 FRAGMENTATION OF A LARGE BLADDER STONE WITH THE STORZ RESECTOR, THE CERAMIC TIP BROKE OFF AND PASSED INTO THE BLADDER. THIS FORCED THE SURGEON TO DO A LAPAROTOMY TO RECOVER THE PART INSIDE THE LAVA. THE CERAMIC COMPLETELY SEPARATED FROM THE SHEATH AND PASSED INTO THE BLADDER. THE SURGERY WAS PROLONGED FOR 1H 30 MINUTES. THE RESECTION OF THE PROSTATE WAS RESCHEDULED 15 DAYS LATER.

  Patient problems: Insufficient Information

  MAUDE report 17671661 ↗