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

Catalog Number	FUS-120035
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
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 during a ureteroscopy procedure that the access sheath was used to gain access into the ureter for dilation.The scope was then placed inside the access sheath and a piece of plastic from inside the access sheath came loose.The access sheath was removed with the plastic piece and another sheath was used to complete the procedure.No known adverse event was reported.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of complaint history, the device history record, drawings, manufacturing instructions, quality control and specifications was performed.A visual inspection and dimensional verification was also conducted.One open package labeled rpn fus-120055, label lot number 8317527 was received.The dilator and sheath were returned unassembled.The clear lining inside the sheath was protruding out past the sheath's distal tip and had an accordion like appearance.The lining was still attached to the inner wall of the sheath near the tip.The inner lining has been scraped and pushed out the end of the sheath.There were no manufacturing anomalies observed with the dilator, lubricity of the components appeared to be sufficient.The device history record was reviewed and one non-conformance was noted for a single device with loose foreign matter.The non-conformance was reworked.A review of complaint history for this product/lot number combination revealed there are no other complaints associated with this product and lot number 8317527.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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the evidence presented by the returned sample and by the customer's testimony, a procedural related event may have contributed to this failure mode.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: 7151714
• Report Number: 1820334-2017-04592
• Device Sequence Number: 918259
• Product Code: KOE
• UDI-Device Identifier: 00827002191686
• UDI-Public: (01)00827002191686(17)201024(10)8317527
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/26/2018

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-120035
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1