MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP STR 20MM; CRANIAL IMPLANTS

Model Number FT790D

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2020

Event Type  malfunction  

Manufacturer Narrative

Without a product an investigation is not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.Since these clips are subject to a 100% inspection of surface, geometry and closing force, a delivery condition with poor geometry can most probably be excluded.

Event Description

It was reported that there was an issue with product yasargil.According to the customer description, it was reported that on (b)(6) 2020 the patient received clipping neuro-surgery for intracranial aneurysm.An aesculap titanium alloy clip ft790 was used.During use it was found the clip was not able to close tightly.Replaced with another clip and the surgery was successful.There was no patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: YASARGIL TI PERM STD-CLIP STR 20MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10741641
• MDR Text Key: 213249230
• Report Number: 9610612-2020-00689
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT790D
• Device Catalogue Number: FT790D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR