MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM CLIP 3.5MM FEN 5/10.1; CEREBRO VASCULAR CLIPS

Model Number FT599T

Device Problem Defective Component (2292)

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

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a yasargil permanent clip.According to the complaint description during surgery abscence of pressure was noted.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.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.If further investigations are required, the product should be provided for examination.

• Brand Name: YASARGIL TI PERM CLIP 3.5MM FEN 5/10.1
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10480217
• MDR Text Key: 207344836
• Report Number: 9610612-2020-00452
• Device Sequence Number: 1
• Product Code: HCH
• UDI-Device Identifier: 04038653171057
• UDI-Public: 4038653171057
• Combination Product (y/n): N
• PMA/PMN Number: K983758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT599T
• Device Catalogue Number: FT599T
• Device Lot Number: 52444798
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1