InjuryEOQ
SINGLE USE BIOPSY VALVE (STERILE)
Received Jul 21, 2026 · Event occurred Jun 30, 2026
Report 3003637092-2026-00152 · MDR key 25897538
Device
Generic name
Bronchoscope (flexible Or Rigid)
Manufacturer
Olympus Medical Systems Corp. Hinode PlantModel number
MAJ-210Lot number
NI
Product problems
- Detachment of Device or Device Component
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
IT WAS REPORTED THAT DURING A DIAGNOSTIC RESPIRATORY PROCEDURE, A BLACK FRAGMENT OF THE SINGLE USE BIOPSY VALVE FELL OFF INSIDE THE PATIENT. THE FRAGMENT WAS IMMEDIATELY RETRIEVED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Remedial action
- Notification