InjuryNBH
STRATOS ENDOSCOPIC RELEASE SYSTEM
Received Jan 9, 2026 · Event occurred Oct 1, 2025
Report 3001617730-2026-00001 · MDR key 24026264
Device
Generic name
Stratos
Manufacturer
A.m. Surgical, Inc.Model number
STRATOS MODEL # 5500Catalog number
STRATOS MODEL # 5500
Lot number
UNKNOWN
Product problems
- Material Separation
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
NONE.
Description of Event or Problem
A COMPLAINT WAS RECEIVED REPORTING THAT A FOREIGN BODY FROM THE STRATOS DEVICE WAS FOUND INSIDE THE PATIENT DURING A SECONDARY SURGERY. THE SECONDARY SURGERY WAS PERFORMED DUE TO PERSISTENT SYMPTOMS THAT HAD NOT RESOLVED FOLLOWING THE INITIAL PROCEDURE FOUR YEARS EARLIER.