ENDO CLIP II
Received Jun 30, 2026 · Event occurred Jun 8, 2026
Report 9612501-2026-01775 · MDR key 25670704
Device
Generic name
Clip, Implantable
Manufacturer
Davis & Geck Caribe LtdModel number
176657Catalog number
176657
Lot number
J6D4239NY
Product problems
- Mechanical Problem
- Difficult to Open or Close
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN OPEN PANCREATECTOMY PROCEDURE, THE CLIP APPLIER WAS USED AND, AFTER A FEW CLIPS WERE APPLIED, THE JAW STOPPED CLOSING AND THE CLIPS DID NOT FORM. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.