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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a ureteroscopy procedure, two wires were placed.Upon advancing the scope onto the working wire, it was noted that the wire was broken at the 3mm tip and the metal piece was exposed.A second wire was used and the same issue occurred.After removing the two wires, it was reported that the stationary wire was bent.An unused wire from the packaging was examined and when placing the demo wire into the casing, the tip bent and was permanently damaged.The patient did not require any additional surgical or medical intervention due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, and specifications 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.There is no indication that a design or process related failure mode contributed to this event.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 device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that during a ureteroscopy procedure, two wires were placed.Upon advancing the scope onto the working wire, it was noted that the wire was broken at the 3mm tip and the metal piece was exposed.A second wire was used and the same issue occurred.After removing the two wires, it was reported that the stationary wire was bent.An unused wire from the packaging was examined and when placing the demo wire into the casing, the tip bent and was permanently damaged.The patient did not require any additional surgical or medical intervention due to this occurrence.

• 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: 5836097
• Report Number: 1820334-2016-00721
• Device Sequence Number: 625651
• Product Code: OCY
• UDI-Device Identifier: 00827002147317
• UDI-Public: (01)00827002147317(17)190524(10)6995062
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2016

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1