MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME EX; PROBE AND VACUUM SET - CE

Model Number	HH11BEX
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hh11bex device was not available for evaluation.The foreign material was returned and evaluated.Fourier transform infrared spectroscopy microscope analysis was completed to determine composition.The white fibers were a 90% match to a polypropylene resin chemistry.The blue fibers were a 78% match to a cellulose-based chemistry.A cellulose/polypropylene blend has applications in a clean room environment that may include, but is not limited to, face masks, absorbent pads, and wipes.The foreign material was found in the collection cup.Based on the design and function of the device the foreign material would not make contact with the patient.
Event or Problem Description
According to the reporter, the event occurred before the procedure.When the probe was removed from packaging and tried to be attached to the holster, a foreign object fell out of the area where the specimen was to be collected.The procedure was completed with the probe without replacing it.The procedure was completed.No patient consequences.

• Brand Name: MAMMOTOME EX
• Common Device Name: PROBE AND VACUUM SET - CE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; tijuana, bc 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241 ; 5138649047
• MDR Report Key: 21985347
• Report Number: 3008492462-2025-00016
• Device Sequence Number: 4287992
• Product Code: KNW
• UDI-Device Identifier: 00841911100942
• UDI-Public: (01)00841911100942(11)090929
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: HH11BEX
• Device Catalogue Number: HH11BEX
• Device Lot Number: F12436459D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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
• Patient Sex: Unknown