MAUDE Adverse Event Report: COOK INC ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G18154
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the roadrunner the firm hydrophilic wire guide was inspected at the time of receipt and a hair was observed inside of the device package.This device was not used on a patient.
Additional Manufacturer Narrative
Investigation/evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, and specifications.A visual inspection of the returned device was also conducted during the investigation.One unopened package was received and labeled with lot number 8464232.Visual observation of the sealed package confirms a hair like fiber loose inside the sealed package.The device history record was reviewed and noted one non-conformance during the manufacturing process.One device with foreign matter embedded in packaging material was identified and the item was reworked.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 8464232.Based on the evidence presented by the sample, the cause of this complaint is likely manufacturing related.Additional measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7346180
• Report Number: 1820334-2018-00477
• Device Sequence Number: 13591988
• Product Code: OCY
• UDI-Device Identifier: 00827002181540
• UDI-Public: (01)00827002181540(17)201221(10)8464232
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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?: Yes
• Operator of Device: Other
• Device Model Number: G18154
• Device Catalogue Number: RPC-035145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 05/01/2018
• Patient Sequence Number: 1