MAUDE Adverse Event Report: STERIS CORPORATION V.MUELLER; SUCTION TUBE

Model Number	U-0552
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with the user facility it was confirmed the device subject of the reported event did not breach the sterile field and had no patient impact.The device subject of the reported event is being returned for evaluation.The investigation is ongoing.A 3-year complaint review indicates this to be an isolated event.A follow-up mdr will be submitted when additional information becomes available.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (mw5157083) that their chroma-line brand taka m suction tube broke apart when the surgeon picked it up prior to use during a patient procedure.The procedure was completed successfully using another chroma-line brand taka m suction tube.No report of injury or procedure delay.
Additional Manufacturer Narrative
The taka suction tube was returned to the supplier for evaluation.Evaluation results determined that excessive force was applied to the device.When the user applied excessive force at the connection of the tube and the handle, it caused the device to break as stated in the reported event.The instructions for use states, "avoid mechanical shock or overstressing the devices." "prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage." steris performed in-service training on the proper use and operation of the taka suction tube, specifically the importance of not bending or applying excessive force while in use.The device history record was reviewed and confirmed the lot was manufactured according to specification; no abnormalities were noted.No additional issues have been reported.

• Brand Name: V.MUELLER
• Common Device Name: SUCTION TUBE
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20151032
• Report Number: 1527821-2024-00012
• Device Sequence Number: 8397055
• Product Code: JOL
• UDI-Device Identifier: 10885403138218
• UDI-Public: (01)10885403138218(10)A24XHE
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: U-0552
• Device Catalogue Number: U0552
• Device Lot Number: (10)A24XHE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown