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

Catalog Number 586008

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

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

Event Type  malfunction  

Manufacturer Narrative

The jaw of the clip was misaligned, which can only be caused by applying great external force to the jaw.Closing function was impaired.The state of the device indicates improper handling during the surgical procedure.

Event Description

Application of excessive force to the jaw part of the clip during a surgical procedure caused clip jaw misalignment and impaired clip function by making it impossible to close the clip properly.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 was damaged 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: 8058151
• MDR Text Key: 128263273
• Report Number: 8010099-2018-00005
• 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: Q388286
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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