SITUATE
Received Feb 6, 2018
Report 3005883396-2018-00014 · MDR key 7245776
Device
Generic name
Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Manufacturer
Mitg - Rf Surgical SystemsModel number
01-0031Catalog number
01-0031
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
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, THE DEVICE WOULD NOT DETECT THE SPONGES. NO PATIENT INVOLVED. NO FURTHER INFORMATION AVAILABLE.
Additional Manufacturer Narrative
EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THIS DEVICE HAD NOT BEEN USED IN THE TREATMENT OR DIAGNOSIS OF THE PATIENT. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. THE REPORTED CONDITION WAS NOT CONFIRMED. THE INVESTIGATION FOUND ALL THE COILS PASSED TESTING ON THE TESTER. THE MAT WAS PLUGGED INTO THE CONSOLE DETECTED SPONGES. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.