MAUDE Adverse Event Report: KEY SURGICAL, LLC. KEY SURGICAL VASCULAR LOOPS; INSTRUMENT, SURGICAL, DISPOSABLE

Model Number	VL-205
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We used the maxi loop that was opened separately from the package.When we tried to put the remel on it, it broke.

• Brand Name: KEY SURGICAL VASCULAR LOOPS
• Common Device Name: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): KEY SURGICAL, LLC.; 8101 wallace rd; eden prairie MN 55344
• MDR Report Key: 16477841
• Report Number: 16477841
• Device Sequence Number: 11550973
• Product Code: KDC
• UDI-Device Identifier: 00849771030874
• UDI-Public: (01)00849771030874(01)136721(17)270729
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2023
• Report Date (Section F): 02/02/2023

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: VL-205
• Device Lot Number: 136721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2023
• 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: Female
• Patient Weight: 103 KG
• Date Report Sent to FDA: 02/02/2023