ENDO PADDLE RETRACT
Received Jun 19, 2026 · Event occurred Jun 2, 2026
Report 2647580-2026-01807 · MDR key 25561479
Device
Product problems
- Difficult to Remove
- Detachment of Device or Device Component
Patient
NA · Unknown
- 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
ACCORDING TO THE REPORTER, DURING A ROBOTIC TOTAL HYSTERECTOMY, THE PADDLE RETRACTOR WAS USED DURING THE PROCEDURE. IT WAS INSERTED THROUGH A 12 MM TROCAR, WHEN THE RETRACTOR WAS REMOVED, THE CLEAR PLASTIC PART WAS FOUND TO BE BROKEN OFF. THE RETRACTOR WAS DIFFICULT TO REMOVE FROM THE PATIENT. NO PATIENT HARM WAS REPORTED.