MAUDE Adverse Event Report: AESCULAP AG YASARGIL APPL.FCPS STD.TI.90/220MM; CRANIAL IMPLANTS

Model Number FT482T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the clamp presented defect during the surgery.According to reports it did not make the correct opening of the clip and because of this the blade of the clip pierced the aneurysm.The patient bleed heavily and stopped.The surgeon managed the situation and clipped it with another key.

Manufacturer Narrative

Investigation: the investigation was carried out by the quality coordinaor of the production plant.Normal signs of wear and tear can be found on the surface.The dimensions w1 (closed position of the forceps) and w4 (release of the clip) are true to gauge.W2 (function of the catch) can not be checked due to the deformed catch.Batch history review: the device quality and manufacturing history records have been checked for the available lot numbers.The device history file 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: 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.Rational: due to the deliberated deformation of the catch, the instrument is no longer according to the delivery condition.A safe application of an aneurysm clip can no longer be guaranteed.No capa is necessary.

• Brand Name: YASARGIL APPL.FCPS STD.TI.90/220MM
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6811935
• MDR Text Key: 83298813
• Report Number: 9610612-2017-00436
• Device Sequence Number: 1
• Product Code: HCI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K940970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT482T
• Device Catalogue Number: FT482T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/18/2017
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other