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

Catalog Number	586008
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ANEURYSM CLIP
• Manufacturer (Section D): MEDICON E.G.; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 8058035
• Report Number: 8010099-2018-00004
• Device Sequence Number: 215672
• Product Code: HCH
• UDI-Device Identifier: 04046826094171
• UDI-Public: 4046826094171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 586008
• Device Lot Number: O314650
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1