VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received May 22, 2026 · Event occurred May 11, 2026
Report 9610773-2026-03969 · MDR key 25260558
Device
Product problems
- Fracture
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE. 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
THE RIGID VIDEO LAPAROSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF NO CUSTOMER ALLEGATION. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, DAMAGED FIBRE BONDING IN THE OUTER TUBE AREA (DISTAL END) AND CUT IN PROTECTOR OF THE VIDEO CABLE SECTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.