POLYSORB
Received Apr 10, 2026 · Event occurred Apr 1, 2026
Report 9612501-2026-01046 · MDR key 24843054
Device
Generic name
Suture, Absorbable, Synthetic, Polyglycolic Ac
Manufacturer
Davis & Geck Caribe LtdModel number
GL-124Catalog number
GL-124
Lot number
A4E1782Y
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, G3 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 LEFT UPPER LUNG LOBECTOMY WITH ROBOTIC MEDIASTINAL LYMPH NODE DISSECTION, AT THE END OF THE PROCEDURE, THE THREE SUTURES FROM THE SAME BOX HAD NEEDLE DETACHMENT. THE THREAD WAS CHANGED THREE TIMES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCTS: GL-124 GL-124 POLYSORB* 0 VIO 75CM V20 X36 - (LOT#A4E1782Y); GL-124 GL-124 POLYSORB* 0 VIO 75CM V20 X36 - (LOT#A4E1782Y); 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 SURGERY, AT THE END OF THE PROCEDURE, THE THREE SUTURES FROM THE SAME BOX HAD NEEDLE DETACHMENT. THE THREAD WAS CHANGED THREE TIMES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.