MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM; CARDIO-THORACIC SURGERY

Model Number FC700SU

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with fc700su-pas-port proximal anastomosis system.According to the complaint description, it was reported that during the surgery there were a product function deviation.The hole in the aorta had to be sutured by hand.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Event Description

The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually.The rotary knob is in its intended end position and the implant is separated from the implant carrier.For a functional test of the product, the device was decontaminated according to internal standards after the first test.The device was then reset, fitted with a new implant and fired.No deviation could be detected during the firing.The implant could be set as intended.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results there is capa is not necessary.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11174247
• MDR Text Key: 226997851
• Report Number: 9610612-2020-01003
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52632015
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention