SITUATE
Received Mar 11, 2026 · Event occurred Feb 19, 2026
Report 1717344-2026-00348 · MDR key 24569646
Device
Generic name
Counter, Sponge, Surgical
Manufacturer
Covidien LlcModel number
01-0043Catalog number
01-0043
Product problems
- False Positive Result
- Device Displays Incorrect Message
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CONSOLE HAD RECEIVED A SCAN OBSTRUCTION WHILE SCANNING THE PATIENT. AFTER THE CASE, TROUBLESHOOTED THE ISSUE AND DETERMINED IT WAS THE SURGICAL LED LIGHTS. WENT INTO A DIFFERENT ROOM AND IT WAS TOGGLING BETWEEN SCAN OBSTRUCTION AND DETECTION WHEN NEAR THE LIGHTS NO MATTER THE INTENSITY WAS TURNED DOWN. IT DID NOT HAPPEN WHEN THE LIGHT WAS TURNED OFF. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D3(MFR NAME AND STREET 1), D4(MODEL NUMBER AND CATALOG NUMBER), G3, H6 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCT: 01-0046, 01-0046 BLAIR PORT WAND X (LOT# UNKNOWN). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT, THE CONSOLE HAD RECEIVED A SCAN OBSTRUCTION WHILE SCANNING THE PATIENT. AFTER THE CASE, TROUBLESHOOTED THE ISSUE AND DETERMINED IT WAS THE SURGICAL LED LIGHTS. WENT INTO A DIFFERENT ROOM AND IT WAS TOGGLING BETWEEN SCAN OBSTRUCTION AND DETECTION WHEN NEAR THE LIGHTS NO MATTER THE INTENSITY WAS TURNED DOWN. IT DID NOT HAPPEN WHEN THE LIGHT WAS TURNED OFF.