ENDO DISSECT
Received Apr 17, 2026 · Event occurred Mar 23, 2026
Report 2647580-2026-01086 · MDR key 24908120
Device
Product problems
- Mechanical Problem
- Failure to Align
Patient
30 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCTS: 176645, 176645 ENDO DISSECT 254 (LOT#:P3M0858), 176645, 176645 ENDO DISSECT 254 (LOT#:P3M0858) 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 BILATERAL INGUINAL HERNIORRHAPHY, THE JAW WAS MISALIGNED AND WHEN ATTEMPTING TO CLOSE, IT FAILED TO SECURELY GRASP THE TISSUE. THREE PACKAGES WERE OPENED UNTIL ONE WAS FOUND THAT ACTUALLY WORKED. THERE WAS NO PATIENT INJURY.