n.a. 26050XARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551092668), received between Aug 20, 2020 and Sep 2, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571552 ↗
• MalfunctionFeb 18, 2025Break; Dent in Material; Break; Dent in Material

  IT WAS REPORTED ON (B)(6) 2025 DURING A HYSTEROSCOPY PROCEDURE THE CERAMIC BEAK TIP OF 26FR INNERSHEATH BROKE OFF IN THE PATIENT. PIECE WAS RECOVERED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402237 ↗
• InjuryNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE DOING A RESECTION UNDER A GYNAE LIST. WHERE THE KARL STORZ GYNAE RESECTOSCOPE SHEATH HAS MELTED AND THE CERAMIC BEAK HAS BROKEN. FORTUNATELY, THE PATIENT AND SAFE AND ALL DEBRIS WERE RETRIEVED INSIDE THE PATIENT'S CAVITY. IT WAS STATED THAT A MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE BROKEN PARTS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. DUE TO THE MEDICAL INTERVENTION, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156275 ↗
• InjuryNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE DOING A RESECTION UNDER A GYNAE LIST. WHERE THE KARL STORZ GYNAE RESECTOSCOPE SHEATH HAS MELTED AND THE CERAMIC BEAK HAS BROKEN. FORTUNATELY, THE PATIENT AND SAFE AND ALL DEBRIS WERE RETRIEVED INSIDE THE PATIENT'S CAVITY. IT WAS STATED THAT A MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE BROKEN PARTS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. DUE TO THE MEDICAL INTERVENTION, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156272 ↗
• MalfunctionDec 7, 2020Material Fragmentation; Material Fragmentation

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): TIP BROKE OFF; THE BROKEN PIECE WAS LEFT BEHIND IN PATIENT'S BODY.

  Patient problems: Insufficient Information

  MAUDE report 10963000 ↗
• MalfunctionAug 20, 2020Material Fragmentation; Material Fragmentation

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): FOLLOWING INFORMATION IS PER FACILITY'S DESCRIPTION OF THE EVENT: DURING RESECTION OF A FIBROID, THE CERAMIC TIP OF THE RESECTOR BROKE OFF AND REMAINED IN THE UTERUS. THE DOCTOR SUCCEEDED IN RECOVERING 2 FRAGMENTS BUT WE CANNOT SAY THAT THERE IS NO MICRO-FRAGMENT LEFT THAT IS INVISIBLE IN ENDOSCOPY (HYSTEROSCOPY). IT WAS NECESSARY TO INCREASE THE DILATATION OF THE CERVIX TO RECOVER THE BROKEN PART. MOREOVER, WE HAD REACHED THE MAXIMUM NUMBER OF RE-INJECTION POCKETS ALLOWED DURING A HYSTEROSCOPY, SO THE PROCEDURE COULD NOT BE FINISHED AND THE PATIENT WILL PROBABLY HAVE TO BE TAKEN BACK TO THE OR. NO CLINICAL CONSEQUENCES NOTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10432036 ↗