MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 customer reported that the tip of standard fixed core wire guide was found broken when the package was opened.The device did not come in contact with the patient.There was no patient harm reported and no additional procedures were required because of this failure.It was further reported that the customer dropped the device package and therefore, the device will not be returned to the manufacturer for further investigation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, quality control and manufacturing instructions was conducted during the investigation.The complaint device was not returned therefore physical examination of the device by the quality engineering and/or engineering departments could not be performed.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.The device history records were reviewed and noted one nonconformance for the work order.The nonconformance was recorded for "bent".This noted nonconformance would have been reworked / repaired prior to further processing.Per review of the device history record there is no indication that the device was not manufactured to specification.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: STANDARD FIXED CORE WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6572590
• Report Number: 1820334-2017-01049
• Device Sequence Number: 662707
• Product Code: OCY
• UDI-Device Identifier: 00827002147317
• UDI-Public: (01)00827002147317(17)190706(10)7099406
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 638413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1