SITUATE
Received Mar 10, 2026 · Event occurred Jan 7, 2026
Report 1717344-2026-00345 · MDR key 24557524
Device
Product problems
- False Negative Result
Patient
31 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A C-SECTION PROCEDURE, THE BODY SCANNER SAID ALL CLEAR MEANING NO LAPS WERE INSIDE THE PATIENT. WHEN THEY COUNTED LAPS THEY KNEW ONE WAS MISSING BUT THE BODY SCANNER SAID ONE WAS NOT MISSING SO THEY USED A LAP SCANNER WAND AND IT WAS DETERMINED THE LAP WAS INSIDE THE ABDOMEN WHICH THEY RETRIEVED BEFORE CLOSING. INSTRUMENTS AND LAPS WERE COUNTED SEVERAL TIMES MANUALLY TO MAKE SURE COUNT WAS CORRECT AND A NEW WAND SCANNER WAS USED AFTER THE CESAREAN SECTION WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
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.