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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event is currently under investigation.
Event or Problem Description
During a ureter - stone litho procedure on the female patient, the wire tip broke and was retrieved with a basket.The laser tech stated the doctor's laser hit it, resulting in the breakage.A section of the device did not remain inside the patient铠body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).**** event evaluation **** during the course of the investigation, a review of the complaint history, quality control, specifications, and trends of the product was conducted.The complaint device was not returned.However, based on the information provided the root cause of the separation was due to the laser contacting the wire guide.There is no evidence to suggest the product was not manufactured to current specifications.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a ureter stone litho procedure on the female patient, the wire tip broke and was retrieved with a basket.The laser tech stated the doctor's laser hit it, resulting in the breakage.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects 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: 5675283
• Report Number: 1820334-2016-00353
• Device Sequence Number: 307177
• Product Code: OCY
• UDI-Device Identifier: 00827002145443
• UDI-Public: (01)00827002145443(17)180816(10)6126375
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/28/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 635413
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2016
• Device Age: 8 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2016
• Supplement Report FDA Received Date: 08/03/2016
• 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