n.a. 27026CORecalls & reported problems
Karl Storz GmbH & Co. KG · Obturator, for 27026C/CB, 27027C/CN · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551074176), received between Apr 17, 2017 and Nov 10, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT 27026C BROKEN DURING SURGERY AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT'S BLADDER. THE DURATION OF THE SURGICAL PROLONGATION WAS BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23512006 ↗InjuryNov 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT 27026C BROKEN DURING SURGERY AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT'S BLADDER. THE DURATION OF THE SURGICAL PROLONGATION WAS BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511990 ↗MalfunctionApr 17, 2017Material Separation; Material Separation
ALLEGEDLY, DURING A CYSTOSCOPY PROCEDURE THE SURGEON NOTICED THE TIP OF THE SHEATH WAS GONE. HE LOCATED THE PIECE IN THE PATIENT'S BLADDER BUT WAS UNABLE TO RETRIEVE IT. PATIENT WAS ADMITTED TO THE HOSPITAL AND THEN RETURNED TO SURGERY THE NEXT DAY FOR AN OPEN PROCEDURE WHEREIN THE TIP WAS RETRIEVED. THE HOSPITAL DID NOT REPORT INJURY TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6499083 ↗
Other endoscopic contamination prevention sheath devices
- n.a. 27026EFKarl Storz GmbH & Co. KG · endoscopic contamination prevention sheath6 reports
- n.a. 27026BOKarl Storz GmbH & Co. KG · endoscopic contamination prevention sheath3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.