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

Model Number VL-205

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Event 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
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): KEY SURGICAL, LLC.; 8101 wallace rd; eden prairie MN 55344
• MDR Report Key: 16477841
• MDR Text Key: 310609113
• Report Number: 16477841
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 00849771030874
• UDI-Public: (01)00849771030874(01)136721(17)270729
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female
• Patient Weight: 103 KG