MAUDE Adverse Event Report: AESCULAP AG YASARGIL TI PERM STD-CLIP BAYO 9MM; YASARGIL TITANIUM ANEURYSM CLIPS PE

Model Number FT758T

Device Problem Defective Device (2588)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).When using the clip for procedure, a surgeon found that the working end was uneven.It was not found when opening it package.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.No deviations on the surface and the symmetry can be found.The jaw parts are even and level.The statement of the customer can not be confirmed.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history files has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: no deviation can be found on the product.Nevertheless, the closing force can no longer be guarantied.It is incomprehensible how often the clip was opened and closed, thus we recommend to no longer use the clip.No capa is necessary.

• Brand Name: YASARGIL TI PERM STD-CLIP BAYO 9MM
• Type of Device: YASARGIL TITANIUM ANEURYSM CLIPS PE
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7589069
• MDR Text Key: 110707229
• Report Number: 9610612-2018-00229
• 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: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: FT758T
• Device Catalogue Number: FT758T
• Device Lot Number: 51965323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Distributor Facility Aware Date: 05/30/2018
• Device Age: 5 YR
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other