MAUDE Adverse Event Report: COOK INC NOVAPASS REVERDIN SUTURE PASSER GEJ CARRIER, LIGATURE

Catalog Number C-PAS-30-11.4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient code: blood loss selected for "bleeding" is not labeled; no code available selected for "required intervention". Device code: no known device issues reported. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the device was used for trans-facial sutures with superior and inferior midline fixation points and 3 lateral fixation points. No perioperative bleeding was noted was reported. However, the patient had to returned to theatre post operatively to control bleeding into the rectus muscle. The surgeon believes the bleeding was due to using the reverdin novapass for the transfascial sutures. Questions have been asked regarding the patient and the event. No further details regarding the patient or event have been provided at this time.

• Brand Name: NOVAPASS REVERDIN SUTURE PASSER
• Type of Device: GEJ CARRIER, LIGATURE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7516383
• MDR Text Key: 108354978
• Report Number: 1820334-2018-01464
• Device Sequence Number: 1
• Product Code: GEJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: C-PAS-30-11.4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/15/2018 Patient Sequence Number: 1