MalfunctionGCP
OUTER SHEATH, 26 FR., 2 STOPCOCKS, ROTATABLE
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 9610773-2026-04867 · MDR key 25782820
Device
Generic name
Endoscope Sheath, Reusable
Manufacturer
Olympus Winter & Ibe GmbhModel number
A22026ALot number
181W-0188
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE PART CONNECTING TO AND SECURING THE INNER SHEATH WAS DAMAGED DURING SETUP/INSPECTION FOR USE ON AN OLYMPUS REUSABLE ENDOSCOPE SHEATH. THERE WAS NO PATIENT INJURY REPORTED.