inforMED
MalfunctionHCI

L-CLIP APPL/REMVR 90 MM RND HANDLE VAR

Received Oct 23, 2013

Report 1045834-2013-29282 · MDR key 3425547

Device

Generic name

Ni

Catalog number

45.441

Lot number

NA

Product problems

  • Device Operates Differently Than Expected

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE APPLIER DEVICE "WOULD NOT HOLD THE ANEURYSM CLIP". IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY.  IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE.  IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

THIS DEVICE IS NOT MANUFACTURED BY COMPANY, THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.