MAUDE Adverse Event Report: COOK INC SPHERE INFLATION DEVICE; KOE DILATOR, URETHRAL

Catalog Number	CID-20-30
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Product code: ptm.Phone: (b)(6).Postal code: (b)(6).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
As reported, prior to an unknown procedure a sphere inflation device was opened when an unknown white substance was found on the handle and the meter.A second device from the same lot was opened and was also found to have the unknown substance on the device.The user then wiped off the second device with gauze and used it in the procedure.No adverse effects occurred due to this occurrence.
Additional Manufacturer Narrative
This report is being submitted as a correction.Upon further review, it has been determined that atrion is the labeled manufacturer of the complaint device and is therefore responsible for all regulatory reporting and complaint investigation requirements.The complaint information has been provided to the manufacturer (atrion) and entered in the complaint file by cook inc.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SPHERE INFLATION DEVICE
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11476190
• Report Number: 1820334-2021-00928
• Device Sequence Number: 3472028
• Product Code: KOE
• UDI-Device Identifier: 10827002310275
• UDI-Public: (01)10827002310275(17)231031(10)96271A003
• Combination Product (Y/N): N
• PMA/510(K) Number: K953522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 10/31/2023
• Device Catalogue Number: CID-20-30
• Device Lot Number: 96271A003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1