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

Model Number	FT599T
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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).
Additional 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
• Common Device Name: CEREBRO VASCULAR CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10480217
• Report Number: 9610612-2020-00452
• Device Sequence Number: 2630842
• Product Code: HCH
• UDI-Device Identifier: 04038653171057
• UDI-Public: 4038653171057
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: FT599T
• Device Catalogue Number: FT599T
• Device Lot Number: 52444798
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1