MAUDE Adverse Event Report: COOK INC FLEXOR URETERAL ACCESS SHEATH AND DILATORS; KOE DILATOR, URETHRAL

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
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
It was reported that while performing an ureteroscopy procedure, the physician used a flexor ureteral access sheath and dilators and noticed that the inside of the sheath frayed.The sheath was removed and a new flexor ureteral access sheath was introduced to complete the procedure.No unintended section of the device remained inside the patient's body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: one used flexor ureteral access sheath was returned for investigation with the dilator and sheath assembled together.Visual inspection noted a severe kink in the flexor assembly in the middle of the device.The most likely cause of the kink damage is due to the manner in which it was returned.Some of the clear lining has been sheared off from inside the sheath and was protruding from the fitting.This device has been scraped on the inside by an instrument of undetermined origin.A review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.Based on the information provided, the actual root cause is due to the handling of the device.A review of the device history records for this product revealed no non-conformances during the manufacturing process that would have caused or contributed to the reported issue.A review of complaint history for this product/lot number combination revealed there have been no other complaints received for lot number 7730901.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6700136
• Report Number: 1820334-2017-01713
• Device Sequence Number: 71802
• Product Code: KOE
• UDI-Device Identifier: 00827002191686
• UDI-Public: (01)00827002191686(17)200307(10)7730901
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: FUS-120035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1