MalfunctionDSA
BIPOLAR CABLE
Received Jul 9, 2026
Report MW5190477 · MDR key 25761417
Device
Generic name
Cable, Transducer And Electrode, Patient, (including Connector)
Manufacturer
Medline Industries, Lp - NorthfieldPatient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE, THE CABLE ON THE BIPOLAR PORT WAS NOT CREATING A GOOD CONTACT AND NEEDS TO BE ROTATED IN ORDER TO ESTABLISH CONTACT, IT WAS NOTED THAT THE CABLE BEING USED IS FROM A THIRD PARTY. THERE WAS NO PATIENT INVOLVED. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".