MAUDE Adverse Event Report: SCANLAN INTERNATIONAL SCANLAN® MULTI-PURPOSE CLAMP; MEDIUM VASCULAR CLAMP

Model Number	2002-16
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The examination of the returned device found significant corrosion, discoloration and pitting.The formation of a pit can be seen on the break line of the jaw.Corrosion on surgical instrumentation is caused by a chemical reaction between the stainless steel and the chemicals, minerals and soiling that the instrument comes into contact with on a daily basis (i.E., detergents, blood and other body fluids, medications, saline, water, etc.).High concentrations of chlorides cause significant corrosion, which can lead to pitting and possible stress fractures.Damage caused by these substances accelerates when combined with the heat, humidity, and pressure of sterilization.The manufacturer's instructions requires inspection between each use cycle and to return the instrument to a scanlan repair center if corrosion cannot be easily removed.Scanlan care & maintenance guide mk-doc-cm rev a troubleshooting guide for surgical instrumentation corrosion and pitting corrosion is a gradual wearing away of a surface, generally by chemical reaction.Corrosion on surgical instrumentation is caused by a chemical reaction between the stainless steel and the chemicals, minerals and soiling that the instrument comes into contact with on a daily basis (i.E., detergents, blood and other body fluids, medications, saline, water, etc.).High concentrations of chlorides cause significant corrosion, which can lead to pitting and possible stress fractures.Damage caused by these substances accelerates when combined with the heat, humidity, and pressure of sterilization.When corrosion breaks through the passive layer of stainless steel, a pit will appear.Pitting (depressions, scars, or cavities) occurs when corrosion is allowed to progress unchecked.An extreme chemical reaction can also cause pitting.Chemicals on sterilization or biological indicators are extremely corrosive to stainless steel and can even cause pitting on an instrument in a single sterilization cycle.Pitting disrupts the integrity of the instrument, changing the way it functions and leading to eventual breakage.When pitting is noted on an instrument, it should be immediately returned to a scanlan-authorized facility to prevent further damage.Corrosion first appears on non-smooth surfaces of instruments, such as box locks, fulcrums, serrations, or knurling, and indicates improper cleaning and care procedures.Early forms of corrosion can be scrubbed away (using only a soft bristle brush).If the corrosion cannot be easily removed, the instrument should be returned to scanlan for repair or restoration to original specifications whenever possible.
Event or Problem Description
"during cabg, while aorta was clamped with gross clamp, it suddenly broke by its self.Surgeon was notified and it was removed from the operating field." as reported.

• Brand Name: SCANLAN® MULTI-PURPOSE CLAMP
• Common Device Name: MEDIUM VASCULAR CLAMP
• Manufacturer (Section D): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer (Section G): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul 55107-1608 ; 6517285759
• MDR Report Key: 19515622
• Report Number: 2126670-2024-00005
• Device Sequence Number: 3315097
• Product Code: DXC
• UDI-Device Identifier: 00846159007442
• UDI-Public: 00846159007442
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: Health Professional
• Device Model Number: 2002-16
• Device Catalogue Number: 2002-16
• Device Lot Number: BC3A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 80 KG