MalfunctionPTS
LOOP CUTTER
Received Jul 31, 2025 · Event occurred Jul 1, 2025
Report 9614641-2025-01292 · MDR key 22674464
Device
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED DURING ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), WHILE SUTURING MUCOUS MEMBRANE (LOCATION UNKNOWN), AFTER CUTTING THE THREAD, THE LOOP CUT PORTION OF THE SUBJECT DEVICE DID NOT OPEN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.