MAUDE Adverse Event Report: AESCULAP, INC. FOGARTY ATRAUMATIC VASCULAR CLAMP; CLAMP, VASCULAR

Model Number	MB095R
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Aortic cross clamp did not close completely to form a seal, used a second cross clamp with the same results.Instrument was quarantined and vendor was notified.

• Brand Name: FOGARTY ATRAUMATIC VASCULAR CLAMP
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): AESCULAP, INC.; 615 lambert pointe dr; hazelwood MO 63042
• MDR Report Key: 20521904
• Report Number: 20521904
• Device Sequence Number: 7920320
• Product Code: DXC
• UDI-Device Identifier: 04046964566752
• UDI-Public: (01)04046964566752
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/30/2024
• Report Date (Section F): 09/30/2024

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
• Operator of Device: Other
• Device Model Number: MB095R
• Device Catalogue Number: MB095R
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Date Report Sent to FDA: 09/30/2024