MAUDE Adverse Event Report: COOK INC TROCAR NEEDLE; DRC TROCAR

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: unknown.Pma/510(k) #: exempt.(b)(4).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 a trocar needle was used for an unknown procedure in an unknown patient.Report states ¿white piece of device feel off and presumed to be in patient¿.Further information has been requested but is currently unavailable.Patient outcome is unknown.In addition, it is not known if segment of device was removed from patient after failure was known.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Description of event: additional information was provided by the customer on 20mar2019.It is unknown whether the small white piece of the device fell in the patient or onto the field.The procedure was completed successfully, and there were no additional procedures required or adverse effects to the patient due to this event.Investigation ¿ evaluation a review of the documentation and quality control of the device were conducted during the investigation.The complaint device was not returned so a physical examination of the device could not be made.Therefore, the device cannot be confirmed to be manufactured out of specification.Lot information is unknown.Therefore, the device history record (dhr) could not be reviewed.Additionally, a review of the sales records to the user facility up to three years prior to the date of event (16nov2017) could not sufficiently narrow down the lot number.As such, potential nonconformances and other complaints under the complaint device¿s lot could not be reviewed.Based on the information provided, no returned product and the results of the investigation, unintended use error is likely to have contributed to the failure mode.A manufacturing cause of failure is not suspected based on review of the device master record, and it is feasible to believe that the depth stop was inadvertently pulled off the needle during a withdrawing motion.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: TROCAR NEEDLE
• Type of Device: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8420131
• MDR Text Key: 138773946
• Report Number: 1820334-2019-00619
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DTN-18-15.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other