SITUATE
Received Jun 26, 2025
Report 1717344-2025-00841 · MDR key 22334698
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
CovidienModel number
L1818-04P01C-RCatalog number
L1818-04P01C-R
Lot number
240407AT
Product problems
- Break
- Detachment of Device or Device Component
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE, A RING DETACHED FROM THE DEVICE AND FELL INTO THE PATIENT. THE RING WAS SUBSEQUENTLY RECOVERED FROM THE PATIENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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 DURING THE PROCEDURE, THE STAFF REMOVED THE RINGS DUE TO A CONCERN THAT THEY MIGHT FALL INTO THE PATIENT. THERE WAS NO PATIENT INCIDENT.