n.a. 28136DSRecalls & reported problems
Karl Storz GmbH & Co. KG · High-Flow Arthroscope Sheath · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551267219), received between Jul 14, 2023 and Jun 10, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2025Break; Break
IT WAS REPORTED THAT "ARTHROSCOPY SURGERY SUCCESSFULLY PERFORMED ON A PATIENT AROUND (B)(6) 2025. THE PATIENT REPORTED POST OPERATION PAINS IN HIS KNEE. THE PATIENT'S POST OPERATION X-RAY EXAM REVEALED A REMAINING FOREIGN BODY IN HIS KNEE. THE PATIENT WAS OPERATED AGAIN AROUND (B)(6) 2025 TO REMOVE THE PART THAT WAS DEEMED MISSING FROM THE SHEATH USED DURING THE SURGERY".
Patient problems: Foreign Body In Patient
MAUDE report 22176852 ↗InjuryJun 10, 2025Break; Break
IT WAS REPORTED THAT "ARTHROSCOPY SURGERY SUCCESSFULLY PERFORMED ON A PATIENT AROUND (B)(6) 2025. THE PATIENT REPORTED POST OP PAINS IN HIS KNEE. THE PATIENT'S POST OP X-RAY EXAM REVEALED A REMAINING FOREIGN BODY IN HIS KNEE. THE PATIENT WAS OPERATED AGAIN AROUND (B)(6) 2025 TO REMOVE THE PART THAT WAS DEEMED MISSING FROM THE SHEATH USED DURING THE SURGERY".
Patient problems: Foreign Body In Patient
MAUDE report 22176546 ↗InjuryJul 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH A 28136DS HIGH FLOW ARTHROSCOPE SHEATH. ACCORDING TO THE INFORMATION RECEIVED THE DOCTOR COMPLETED A SHOULDER ARTHROSCOPY CASE ON (B)(6) 2023. THE FOLLOW UP X-RAY WAS COMPLETED ON (B)(6) AND FOUND THAT THE TOP FENESTRATED PEACE OF THE DUAL STOPCOCK SHEATH WAS BROKEN AND STAYED IN THE PATIENT'S SHOULDER SOFT TISSUE. PATIENT HARM IS NOT KNOWN AT DATE OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE PATIENT IS SCHEDULED FOR A SECOND SURGERY TO REMOVE THE BROKEN PIECE.
Patient problems: Insufficient Information
MAUDE report 17324546 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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