InjuryGEI
BOWA RETURN ELECTRODE
Received Jul 26, 2023
Report MW5120278 · MDR key 17415511
Device
Generic name
Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer
Bowa-electronic Gmbh & Co. KgModel number
818-162Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER CNF, IT WAS REPORTED THAT: A BOWA 818-162 RETURN ELECTRODE WAS BEING USED. THE DEVICE HAD PREVIOUSLY BEEN USED WITHOUT ANY PROBLEM, BUT FOR THE FIRST TIME TODAY, IT COULD NOT BE RECOGNIZED. THEREFORE, THE DEVICE WAS REPLACED WITH A SINGLE TYPE RETURN ELECTRODE AND THE PROCEDURE WAS PERFORMED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B) (2).