MAUDE Adverse Event Report: COOK INC URETHRAL DILATOR SET; KOE DILATOR, URETHRAL

Catalog Number	073701
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 a hair can be seen in the pouch which the urethral dilator set was packaged in.Therefore, the user didn't use the urethral dilator set as the sterilization may have been compromised.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 examination of the returned device was conducted.A review of complaint history, the device history record, quality control data and specifications was also performed.One unopened package labeled rpn 073701 with label lot number 8552127 was received.Visual examination of the package confirmed a dark color hair resting on the dilators inside the sealed package.The device history record was reviewed and no non-conformances were found related to the reported issue.A review of complaint history no other complaint associated with the complaint device lot number 8552127.The cause of this complaint is manufacturing related.Measures have been initiated to address the issue of foreign matter.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It was reported that a hair can be seen in the pouch which the urethral dilator set was packaged in.Therefore, the user didn't use the urethral dilator set as the sterilization may have been compromised.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.

• Brand Name: URETHRAL DILATOR SET
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7515876
• Report Number: 1820334-2018-01474
• Device Sequence Number: 1169783
• Product Code: KOE
• UDI-Device Identifier: 00827002141858
• UDI-Public: (01)00827002141858(17)210131(10)8552127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K811833
• 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): 06/22/2018

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: 073701
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1