PURSTRING
Received Apr 7, 2026 · Event occurred Apr 1, 2026
Report 2647580-2026-00971 · MDR key 24799099
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
D10. CONCOMITANT PRODUCTS: TRIEEAXL28XT CIR STPLR TRIEEAXL28XT BLK EXT - (LOT#UNKNOWN). 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 LAPAROSCOPIC LOW ANTERIOR RESECTION, DURING ANASTOMOSIS, THE ANVIL AND RELOAD OF THE CIRCULAR STAPLER WERE FULLY CONNECTED BUT THERE WERE HOLES IN THE STAPLE LINE. THE SECOND DEVICE WAS FIRED AND THERE WAS A STAPLE LINE BLEEDING. THE SURGEON RESECTED AND RESTAPLED THE ANASTOMOSIS TO RESOLVE THE ISSUE.