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

Catalog Number	FUS-120045
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
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
The distributor reported that prior to use, the user facility observed a white stain at the distal end of the flexor ureteral access sheath.This device was not used.There was no contact with the patient.As reported, there was no impact to the patient.
Additional Manufacturer Narrative
Report source - other: (b)(6).Investigation summary: a review of the complaint history, instructions for use (ifu), device history record, specifications and a visual inspection of the returned device were conducted during the investigation.One opened complaint device was returned for investigation.Photos are provided.Dilator and sheath returned assembled together; the hub was secured inside a plastic hub protective snap pack.Under magnification, the outer surface of the sheath material had been scraped 1.5cm from the distal tip.The coating on the sheath had been scraped off the surface.There were no pieces of sheath coating returned.No obvious manufacturing anomalies were identified or confirmed on the returned sample.Based on the evidence presented by the sample and the physical analysis, this device has been damaged by an instrument of unknown origin.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found (b)(4) non-conformance associated with the complaint device lot number which were identified and reworked prior to further processing.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined, however; based on the provided information, and the device evaluation, the probable root cause is deemed to be; ¿product use or handling related".However, appropriate measures have been initiated to address this failure mode.The quality engineering risk assessment for this failure mode was reviewed and it was determined that risk mitigation activities are being investigated.The appropriate personnel will be notified and we will continue to monitor 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: 6983508
• Report Number: 1820334-2017-03747
• Device Sequence Number: 18994946
• Product Code: KOE
• UDI-Device Identifier: 00827002461680
• UDI-Public: (01)00827002461680(17)200706(10)8042910
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: Health Professional
• Device Catalogue Number: FUS-120045
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1