MAUDE Adverse Event Report: COOK INCORPORATED QUANTUM TTC; DILATOR, ESOPHAGEAL

Model Number	G22312
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon popped during inflation.

• Brand Name: QUANTUM TTC
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 16655050
• Report Number: 16655050
• Device Sequence Number: 5821865
• Product Code: KNQ
• UDI-Device Identifier: 00827002223127
• UDI-Public: (01)00827002223127(17)250215(10)W4565557
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/28/2023
• Report Date (Section F): 02/28/2023

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 Model Number: G22312
• Device Catalogue Number: QD-16X8
• Device Lot Number: W4565557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 91 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 02/28/2023