ENDO CLIP III
Received Jul 6, 2026 · Event occurred Jun 10, 2026
Report 9612501-2026-01809 · MDR key 25718709
Device
Generic name
Clip, Implantable
Manufacturer
Davis & Geck Caribe LtdModel number
176630Catalog number
176630
Lot number
J5L3086Y
Product problems
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PREOPERATIVELY, A WHITE PLASTIC PIECE OF THE DEVICE BROKE. THERE WAS NO PATIENT INVOLVED.
Additional Manufacturer Narrative
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.