LIGHTED RESTRACTOR SOLSTICE B1
Received Apr 10, 2026 · Event occurred Mar 18, 2026
Report 2182208-2026-18712 · MDR key 24845024
Device
Generic name
Retractor
Manufacturer
Medtronic Perfusion SystemsModel number
50-101-1Catalog number
50-101-1
Lot number
A293
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEBRIS WAS FOUND ONLY IN THE HANDPIECE PACKAGING WHICH WAS NEVER OPENED, NO DAMAGE TO THE INSTRUMENT REPORTED.
Additional Manufacturer Narrative
B5 UPDATED WITH NEW INFORMATION RECEIVED. 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.
Additional Manufacturer Narrative
(H3,H6): NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES B17, C20 <(>&<)> D15 ARE APPLICABLE. 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
INFORMATION WAS RECEIVED FROM A MEDTRONIC REPRESENTATIVE ON BEHALF OF HEALTHCARE PROVIDER REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE WAS DAMAGED AND STERILE PACKAGING OF HANDPIECE WAS OBSERVED TO HAVE DEBRIS INSIDE. THERE WAS NO PATIENT INVOLVED.