MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM; ANASTOMOSIS DEVICES

Model Number FC700SU

Device Problem Product Quality Problem (1506)

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

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual investigation: in similar cases like the present one, the investigation did not reveal any abnormalities on the pas-port device and the individual parts itself.No damages could be found which may explain the failure pattern.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 4(5) x probability of occurrence 2(5)) 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.Currently the product is not sold nor marketed anymore.Recall was initiated to prevent further complications.

Event Description

It was reported that there was an issue with fc700su - pas-port proximal anastomosis system.According to the complaint description, only a hole was opened in aorta and the procedure was performed with using the side clamp when using pps.The surgeon hold the hole with finger to stop bleeding.The side branches were treated with sutures of 4-0 or less, and did not become too large like a ball.There was no resistance when turning the knob, and it was unlocked.Since svg was visible from the tip of the pps body from , it was pulled out in a clean field.Both the inner and outer flanges of the stapler were properly opened but there was no resistance like a staples slipping out, and only a hole was made in the ao.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under(b)(4).

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Type of Device: ANASTOMOSIS DEVICES
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12121238
• MDR Text Key: 260047050
• Report Number: 9610612-2021-00514
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/05/2021

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: 03/30/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52624647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention