MAUDE Adverse Event Report: MEDICON E.G. YASARGIL CLIP; ANEURYSM CLIP

Catalog Number 586008

Device Problems Fracture (1260); Material Twisted/Bent (2981); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The clip brace was slightly bent and had broken near one end.Closing pressure and closing function were found to be within specifications.The bent brace and the traces of blood found on the clip indicate improper handling during the surgical procedure.Apparently force was applied to the clip by another object, first bending and finally breaking the brace.

Event Description

During a surgical procedure, undue force seems to have been applied to the clip with a foreign object, leading to breakage.The patient did not suffer any harm.No further information has been provided by the distributor, who first indicated that the malfunction occurred during use of the device, and then that it broke during cleaning and sterilization prior to first use.The second statement does not hold, since the returned device showed traces of blood.

• Brand Name: YASARGIL CLIP
• Type of Device: ANEURYSM CLIP
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anton mittermueller ; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8058035
• MDR Text Key: 128627007
• Report Number: 8010099-2018-00004
• Device Sequence Number: 1
• Product Code: HCH
• UDI-Device Identifier: 04046826094171
• UDI-Public: 4046826094171
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 586008
• Device Lot Number: O314650
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1