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

Model Number N/A

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

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Class i device.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the internal investigation.

Event Description

The physician / device user reported slashing her right index finger with the novapass straight suture passer during a procedure on an unspecified date.The physician / device user was seen in the emergency room; sutures were offered to close the wound.The physician declined the offer.The reporting physician / user was performing an unspecified procedure on a patient that was described as having a thick abdominal wall; the patient tested negative for blood borne pathogens.No further information is available.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, instructions for use (ifu), specifications 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 an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "do not use the suture passer in a procedure where the position of the needle tip cannot be clearly identified.Novapass suture passers have needle-point tips that can cause injury to internal tissue and/or any personnel who may come in contact with the device.The needle-point tip should be kept protected with the protective cap whenever the device is not in use." based on the information provided, no product returned and the results of our investigation, user technique / user error contributed to the event.We will continue to monitor for similar complaints.Measures are being conducted to address this failure mode.

• Brand Name: NOVAPASS STRAIGHT SUTURE PASSER
• Type of Device: GEJ CARRIER, LIGATURE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6269422
• MDR Text Key: 65468817
• Report Number: 1820334-2017-00085
• Device Sequence Number: 1
• Product Code: GEJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PAS-180-16.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention