inforMED
MalfunctionHCI

L-CLIP APPL/REMVR 210 MM VARIABLE

Received Apr 4, 2013 · Event occurred Mar 4, 2013

Report 1045834-2013-01355 · MDR key 3042889

Device

Catalog number

45.421

Product problems

  • Sticking
  • Difficult to Open or Close

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

REPORT RECEIVED FROM THE USA STATING THAT THE "LATCH IN THE MIDDLE IF THE DEVICE WAS STUCK IN THE LOCK POSITION AND WOULD NOT RELEASE." THE REPORTER WAS UNABLE TO CONFIRM WHETHER OR NOT THE DEVICE WAS BEING USED DURING PRETESTING SET UP FOR AN ANEURYSM SURGERY OR IF DISCOVERED DURING SURGERY. IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.