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

Model Number FG-000001-14

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 pas-port proximal anastomosis device.According to the complaint description the packaging is broken.During the incoming goods inspections it was noted that the packaging was broken.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the instrument arrived in the original box and sealed blister.The supposedly defective area was marked with a tag.Goods incoming inspection complaint, product was not in clinical use.Various tests were performed to check the sterile barrier of the packaging.No leaks or damage to the packaging could be detected.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.The error image complained about cannot be confirmed.

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: 10276016
• MDR Text Key: 199670531
• Report Number: 9610612-2020-00273
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 200108D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1