MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STDRT ANG 2.5BAYO 5MM; CRANIAL IMPLANTS

Model Number FT770T

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Investigation results: vigilance investigator carried out the pictorial documentation microscopically.The points of the jaw are no longer even.Nevertheless, the closing force is within the specification and the jaw is closing probably.No other deviations can be found on the provided product.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: since the yasargil clips are subject to a times 100% control, we can exclude that this product was delivered in this condition.As described by the costumer: "the product was sheared in use." the uneven points are most likely caused by an insufficient usage, i.E.Leverage.For that reason, an intraoperatively injury of the tissue cannot be excluded.

Event Description

It was reported that there was an issue with the product yasargil clip.The product was sheared in use and the aneurysm neck was torn.Additional information was not provided.The malfunction is filed under aag reference (b)(4).

• Brand Name: YASARGIL TI PERM STDRT ANG 2.5BAYO 5MM
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9146155
• MDR Text Key: 161087604
• Report Number: 9610612-2019-00687
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970050
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT770T
• Device Catalogue Number: FT770T
• Device Lot Number: 52242549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other