• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC NOVAPASS REVERDIN SUTURE PASSER GEJ CARRIER, LIGATURE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVAPASS REVERDIN SUTURE PASSER
Type of DeviceGEJ 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 Key7516383
MDR Text Key108354978
Report Number1820334-2018-01464
Device Sequence Number1
Product Code GEJ
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
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 Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberC-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 Received07/10/2018
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
-
-