MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	MF513R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a frazier slot suct tube ang 7fr 180mm) part # mf513r) was used during an acdf c 4-5, 5-6, 6-7 sometime in (b)(6) 2024.According to the complainant the device suction broke at weld point where suction attaches to adapter/luer.Reportedly the pieces were retrieved and an x-ray was performed to confirm all pieces were removed.A new suction was opened and used to complete the procedure.A ten-minute delay to the procedure was also reported.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4) cc 400713732.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).One (1) sample provided was returned to the manufacturing site for technical evaluation.Results of the investigation determined visually that the suction tube showed heavy signs of use such as deep scratches and dings.The instrument did not have the production identifiers that are normally marked on the instrument.Based on the investigation findings, the break most likely resulted from handling.As a result, the reported failure could not be confirmed to be a manufacturing related issue.

• Brand Name: AESCULAP
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22296729
• Report Number: 2916714-2025-00036
• Device Sequence Number: 15533547
• Product Code: GEA
• UDI-Device Identifier: 04046964573071
• UDI-Public: (01)04046964573071
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MF513R
• Device Catalogue Number: MF513R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female