MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. SCANLAN VASCU-STATT PLUS; SINGLE USE BULLDOG CLAMP

Model Number	1001-572
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our inital investigation reviewed product stock, and manufacturing records no non-conformities identifed in these records.The risk file was reviewed.The product was received for evaluation on 2/6/26.Visual inspection of the clamp was performed.The clamp is within specification.No non-conformities were identified.As the device is intended for general surgical use, vasculature with anatomical variability resultant of the disease state or occurring congenitally may be selected for occlusion at the discretion of the professional user.Such variation may result in reduced suitability or efficacy of the device when applied to the vessel; however, no systemic pattern of this occurrence has been identified.Root cause analysis no nonconformities were noted.Unable to ascertain the root cause of this reported issue with the available information.
Event or Problem Description
Scanlan was contacted regarding a vascu stat plus not fully functioning.The end user stated on 01/09/2026, there was a problem with the vascu stat plus 1 x 1001-572 (lot #: 8204001).The hospital reported that during the case the bulldog clamp didn't close fully on the tip.They had to use another bulldog clamp.It worked without any problem and there was no harm to the patient.Since theoretically a not fully closed bulldog can lead to a patient problem, the hospital decided to report this event as a vigilance case to swiss medic.Additional information received 1/14/2026 the surgeon was applying the clamp to the internal mammary artery, and when the surgeon recognized bleeding on the clamp side, he used a new clamp without any issue.He stated that the clamping pressure was not enough to properly occlude the vessel.The tips of the foam clamp jaws were more open, and the clamp jaws did not fully close and occlude the vessel.

• Brand Name: SCANLAN VASCU-STATT PLUS
• Common Device Name: SINGLE USE BULLDOG CLAMP
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul MN 55107 1681
• Manufacturer (Section G): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; saint paul MN 55107 1681
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul, MN 55107-1681 ; 6517285759
• MDR Report Key: 24283745
• Report Number: 2126670-2026-00002
• Device Sequence Number: 8580029
• Product Code: GDJ
• UDI-Device Identifier: 00846159000818
• UDI-Public: (01)00846159000818
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: 1001-572
• Device Catalogue Number: 1001-572
• Device Lot Number: 8204001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown