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U.S. Department of Health and Human Services

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

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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 were asked about the patient and the event. At this time, no further details regarding the patient or event have been provided.
 
Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, documentation, instructions for use (ifu), and quality control was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly, a review of the device history record could not be conducted. The device is shipped with instruction for use (ifu) which notes: "exercise extreme caution during use of this device to avoid unintentional puncture/perforation of vessel, never, bowel, or any other internal organs or vital anatomical structures. ¿ also, ¿do not use suture passer in a procedure where the position of the needle tip cannot be clearly identified. ¿ clinical assessment cannot eliminate any possible causes for this event such as product handling, medical procedure, patient physiology, device failure, or manufacturing related causes. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
 
Event Description
No additional information has been reported since the submission of the initial report on 5/15/2018.
 
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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 Key7516450
MDR Text Key108352163
Report Number1820334-2018-01469
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2018
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
Device Lot NumberUNKNOWN
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? Device Not Returned to Manufacturer
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
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