ENDO RETRACT
Received Feb 3, 2026 · Event occurred Jan 28, 2026
Report 2647580-2026-00266 · MDR key 24251898
Device
Product problems
- Detachment of Device or Device Component
- Noise, Audible
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADRENALECTOMY, THE GREEN HANDLE SEPARATED FROM THE LONG SHAFT OF THE RETRACTOR WHILE A RESIDENT WAS ROTATING THE HANDLE TO OPEN THE THREE FINGERS OF THE RETRACTOR TO SUPPORT THE LIVER. IT WAS DIFFICULT TO REMOVE THE RETRACTOR OUT OF THE BELLY THEN BUT THE DEVICE WAS ULTIMATELY REMOVED BY THE ATTENDING PHYSICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
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.