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

Model Number	G19168
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
In preparation for a flexible ureteroscopy the access sheath was flushed with sterile water which activates the hydrophilic coating.When the sterile water was flushed through the sheath, the sterile water appeared to have debris in it and the sterile water was cloudy in appearance.Another sheath was opened with no further issues.There was no patient contact with the sheath in question.
Event or Problem Description
There has been no new event information received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, quality control data, and specifications.The customer returned one opened package labeled with part number fus-120035 and lot number 8860824 for investigation.Visual examination of the sheath assembly confirmed dilator and sheath were received assembled together.No physical anomalies were observed on the device.The length of the sheath 35cm.The dilator extends 3.5cm from distal end of sheath.All length dimensions are within specification.During a physical examination, the dilator was removed from the sheath, dry aq coating was seen on the inside perimeter 3.5cm behind the distal tip at the edge of the coil.Evidence shows aq coating has been previously activated.When sheath was flushed with water no loose debris was removed.A review of the device history record for lot number lot 8860824 showed one non-conformance.The non-conforming products were removed from the lot.This product is inspected 100% prior to distribution.There is no evidence suggesting nonconforming product was released for distribution.A review of complaint history revealed there have been no other complaints associated with the complaint device lot number 8860824.The returned fus-120035 was found to have debris on the outside of the dilator.Hydrophilic coating was visible at the edge of the coil inside the sheath and appeared to have been previously activated.When the sheath was flushed with water, no loose debris was removed.The source of the debris could not be determined in this instance.The device appears to have been manufactured to specifications.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Investigation conclusion is cause could not be established.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8363148
• Report Number: 1820334-2019-00494
• Device Sequence Number: 1920902
• Product Code: KOE
• UDI-Device Identifier: 00827002191686
• UDI-Public: (01)00827002191686(17)210503(10)8860824
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K961904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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 Expiration Date: 05/03/2021
• Device Model Number: G19168
• Device Catalogue Number: FUS-120035
• Device Lot Number: 8860824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERILE WATER