MalfunctionLWH

SITUATE

Received Nov 15, 2021 · Event occurred Oct 28, 2021

Report 3005883396-2021-00030 · MDR key 12813613

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Mitg - Rf Surgical Systems

Model number

01-0046

Catalog number

01-0046

Product problems

False Negative Result
False Negative Result

Patient

Unknown

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, POST-OPERATIVELY, THE DEVICE WAS NOT WORKING WHEN CONNECTED. THE WAND WAS NOT DETECTING EVEN PRESENT. REPLACED WITH ANOTHER SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.