inforMED
MalfunctionJOS

HF-RESECTION ELECTRODE "PLASMALOOP MEDIUM, 30", LOOP, 24 FR., STANDARD

Received Aug 31, 2021 · Event occurred Aug 26, 2021

Report 9610773-2021-00239 · MDR key 12390345

Device

Generic name

Hf-resection Electrodes

Model number

WA47506S

Catalog number

WA47506S

Lot number

1000067135

Product problems

  • Break
  • Fracture
  • Material Fragmentation
  • Mechanical Problem
  • Break
  • Fracture
  • Material Fragmentation
  • Mechanical Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, SINCE THE X-RAY EXAMINATION SHOWED THAT THERE WERE NO FOREIGN OBJECTS INSIDE THE PATIENT, IT IS ASSUMED THAT THE LOOP WIRE ONLY BROKE THROUGH WITHOUT A FRAGMENT BREAKING OFF. A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE RESECTION ELECTRODE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES.