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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, during a lithotripsy procedure, a trocar needle was employed to provide routine access to the patient's kidney.A zipwire brand guidewire (which was not of cook manufacture) was then threaded through the trocar needle, which was also reportedly per procedure.When the physician began to pull the guide wire out of the assembly, the trocar peeled the zip wire and cut some of the edges of the wire off.These pieces disengaged into the patient's cavity, but were successfully removed in their entirety by the operator.The only unexpected outcome for the patient was an extension to the surgery time of about 20 minutes.The product is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Additional information: investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The cannula was returned with protector sleeve.A guide wire was returned inside the lumen of the cannula.The guide wire was difficult to remove.The black coating of the wire is stripped and peeling off.No trocar stylet was returned.There are four indentions on the outer diameter of the cannula which appear to be consistent with a hemostat or other similar tool.A slight "bow" was noticed in the cannula.The cannula was cut twice to allow for removal of the wire guide and measurement of the cannula inner diameter.No burr was noticed at the end of the cannula; it appeared clean and rounded.The length and inner diameter of the cannula were within cook manufacturing specifications.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record showed three non-conformances; however, all non-conforming product was re-worked prior to completion of the final lot.In addition, there were no other reported complaints for this lot number.The complaint states that the guide wire was pulled through the trocar needle.Standard practice is never to pull a wire guide through a needle as it would cause shredding, kinking or breakage.There is no evidence that the needle was not manufactured to specifications.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined, however, it is likely that due to the end user pulling the wire guide through the needle, the peeling of the coating is a result of this action and not of a manufacturing defect of the product.

• Brand Name: TROCAR NEEDLE
• Common Device Name: DRC TROCAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6993079
• Report Number: 1820334-2017-03717
• Device Sequence Number: 1299178
• Product Code: DRC
• UDI-Device Identifier: 00827002013773
• UDI-Public: (01)00827002013773(17)220607(10)7971622
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DTN-18-20.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention