MalfunctionLWH

SITUATE

Received Apr 27, 2021 · Event occurred Apr 8, 2021

Report 3005883396-2021-00010 · MDR key 11735578

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Mitg - Rf Surgical Systems

Model number

01-0043

Catalog number

01-0043

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

THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A DETECTION ISSUE. DETECTED BUT NOT THERE. THE CUSTOMER WANTS TO KNOW IF THE DEVICE DETECTION SYSTEM CAN DETECT THE PRODUCT, THE PATIENT WAS WEARING A DIAPER WITH AN IMBEDDED RF CHIP. THERE WAS NO PATIENT INJURY.