MalfunctionLWH

SITUATE

Received Oct 5, 2021 · Event occurred Sep 20, 2021

Report 3005883396-2021-00027 · MDR key 12578526

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Mitg - Rf Surgical Systems

Model number

01-0034R

Catalog number

01-0034R

Product problems

False Positive Result
False Positive Result

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DETECTING ITEMS THAT ARE NOT THERE. THE EXTRA COUNTS THAT WERE EXPERIENCED WAS DUE TO SOME LEFT IN THE BED FRAME. THE UNIT WAS WORKING AS IT SHOULD. THERE WAS NO PATIENT INVOLVEMENT.