MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIPSLT-CVD13.7MM; CEREBRO VASCULAR CLIPS

Model Number FT782T

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

If additional information or investigation results are provided, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with yasargil ti perm std-clipslt-cvd13.7mm.The product package was opened before the operation and it was found that the product head was not aligned.It was then replaced by a new one.There was no patient harm.Additional information was not provided.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was provided for investigation.Investigation was carried out visually and microscopically.Traces of usage and a misaligned jaw yould be detected.The device quality and manufacturing history records (dhr) have been checked for the available lot number 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 with this error pattern.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.Due to the fact that the product was repaired, we cannot determine the exact root cause for the mentioned deviation.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: YASARGIL TI PERM STD-CLIPSLT-CVD13.7MM
• Type of Device: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10534962
• MDR Text Key: 206960557
• Report Number: 9610612-2020-00501
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• PMA/PMN Number: K970050
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT782T
• Device Catalogue Number: FT782T
• Device Lot Number: 52522425
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1