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

Model Number FG-000001-14

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

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.It was reported that during the surgery the implant could not be retracted.There was no patient harm.This malfunction did not prolong the surgery.Additional information was not provided nor available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

General information intra operative incident.The instrument arrived in contaminated condition.Consequences for the patient according to the available information, there were no negative consequences for the patient.Investigation used test- and analysis- equipment: microscope "keyence- vhx 5000 " eq.-nr.2000024840.Digital-camera "panasonic dmc tz8." we carried out a visual inspection of the various components.The delivery tool itself was not used, also the poke- through instruments are in a unused condition.At the tip of the pull through instrument we noticed, that the wire hook was completely deformed.For comparison an extract of the construction drawing shows the specification shape of the wire hook.Batch history review the manufacturing documents have been checked and found to be according to specification valid during the time of production.There is no further complaint with this lot at hand.Conclusion the root cause can not definitely determined.Rationale material defect or manufacturing failure can be excluded.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10168325
• MDR Text Key: 198931531
• Report Number: 9610612-2020-00214
• 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
• 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: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 200108K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1