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

Catalog Number	FUS-095045
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/20/2018
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
It was reported that the user received the flexor ureteral access sheath and dilators with a particle inside it.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A visual inspection of the returned device was also conducted.A review of complaint history, the device history record, manufacturing instructions, quality control data and specifications was performed.One unopened package labeled rpn fus-095045 with label lot number 8513128 was received.Visual examination confirmed white paper like foreign matter was loose within the sealed package.Review of the device history records found no non-conformances associated with this complaint device lot number.A review of complaint history revealed there are no other complaints associated with the complaint product lot number 8513128.A document review was carried out and it was identified that the product line was inspected for foreign matter after being packaged.There were no additional complaints or non-conformances identified on the same lot.The cause of this complaint is manufacturing related.Measures have been initiated to address this failure.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: 7451913
• Report Number: 1820334-2018-01186
• Device Sequence Number: 19140741
• Product Code: KOE
• UDI-Device Identifier: 00827002461673
• UDI-Public: (01)00827002461673(17)210116(10)8513128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: No Information
• Device Catalogue Number: FUS-095045
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1