MAUDE Adverse Event Report: COOK INCORPORATED SAVARY; DILATOR, ESOPHAGEAL

Model Number	G22678
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Savary brush didn't have the brush.It was a sharp end instead of the brush.

• Brand Name: SAVARY
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 20223754
• Report Number: 20223754
• Device Sequence Number: 12699088
• Product Code: KNQ
• UDI-Device Identifier: 00827002226784
• UDI-Public: (01)00827002226784
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/08/2024
• Report Date (Section F): 05/08/2024

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
• Device Model Number: G22678
• Device Catalogue Number: SCB-1-S
• Device Lot Number: W4819698
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/08/2024