MAUDE Adverse Event Report: AESCULAP AG YASARGIL APPL.FCPS STD.TI.90/220MM; INSTR./ACCESS.YASARGIL TITANIUM ANE

Model Number FT482T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).During a surgical procedure the tweezers did not hold the clip accurately and after clipping, the clip did not release properly.Due to this the patient's aneurysm ruptured.The patient was taken to intensive care in serious condition and the patient died.

Manufacturer Narrative

Investigation: the investigation was carried out visually.At the working end, at the prism, significant deformations can be found, thus a functional test can not be carried out.The jaw is not true to gauge and the opening range of the handles is too tight.The catch is missing completely.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 maintenance of the device.Rational: the forceps shows significant signs of wear and tear, most likely caused by improper usage.In particular the jaw is very damaged and not longer according to the specifications.Corrective action: according to sop sa-de13-m-4-2-01-010.A capa is not necessary.

• Brand Name: YASARGIL APPL.FCPS STD.TI.90/220MM
• Type of Device: INSTR./ACCESS.YASARGIL TITANIUM ANE
• 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
• MDR Report Key: 6609652
• MDR Text Key: 76596444
• Report Number: 9610612-2017-00281
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2017
• Date Manufacturer Received: 05/04/2017
• 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): Death