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

Model Number FG-000001-14

Device Problem Product Quality Problem (1506)

Patient Problem Failure to Anastomose (1028)

Event Date 08/08/2020

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 a pas-port proximal anastomosis device.According to the complaint description bleeding occured from the anastomosed point and one wing of the outer flange was sticking out at the point.The point was clamped, the svg was retrieved and it was anastomosed by hand under off pump as an intervention method.An additional medical intervention was necessary.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

The reportability was reassessed and found to no longer require submission - aesculap is not the legal manufacturer of this device.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE
• Type of Device: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10580276
• MDR Text Key: 208341220
• Report Number: 9610612-2020-00495
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K091017
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 191014F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention