OCTOBASE RETRACTOR RACK
Received Apr 8, 2026 · Event occurred Feb 1, 2026
Report 2184009-2026-00441 · MDR key 24813176
Device
Product problems
- Break
Patient
54 YR · Male
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
2.4.4 PMA/510 K:HAS NOT BEEN POPULATED AS THIS DEVICE IS A CLASS I EXEMPT DEVICE. 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 USE OF AN OCTOBASE RETRACTOR THE DEVICE WAS BEING USED IN A PATIENT FOR AORTIC VALVE AND AORTIC ROOT REPLACEMENT WHEN THE CRANK HANDLE BROKE OFF LEAVING THE RETRACTOR STUCK IN THE PATIENT. THE USE OF THE DEVICE WAS UNSPECIFIED.