MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME REVOLVE; STEREOTACTIC PROBE - NON-GLASS FALCON - CE

Model Number	MST1012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, metal shards were retained within the patient after completion of the biopsy.The shards are seen post-maker placement on both cranial caudal and mediolateral oblique post-films.In the mammography slices, they are seen on the 3rd and 6th slices.The shards are not in the biopsy cavity but on the superficial skin surface.The problem occurred during the procedure.The procedure was completed with the reported mst1012.
Additional Manufacturer Narrative
The st probe (along with its integrated components: specimen management system and vacuum tube set) is a sterile, single-patient use device that may be used with imaging guidance to excise a tissue sample for diagnosis.The probe is designed to be loaded onto the st holster.The probe consists of an outer needle shaft and an inner cutter in a distal sample aperture.The sample aperture can be rotated to the desired orientation using either the probe's aperture rotation thumbwheel or the st holster aperture rotation knobs.According to the reporter, metal shards were retained within the patient after completion of the biopsy.The shards are seen post-maker placement on both cranial caudal and mediolateral oblique post-films.In the mammography slices, they are seen on the 3rd and 6th slices.The shards are not in the biopsy cavity but on the superficial skin surface.The problem occurred during the procedure.The procedure was completed with the reported mst1012.There was no medical intervention/surgery to treat the patient.The metal shards were not removed from the patient.The metal shards were only viewed on mammography.The mst1012 was received for evaluation.The probe was received along with 2 hemostats and a scalpel.Mammotome is not the manufacturer of the hemostats nor scalpel.The needle and cutter that would interact with the patient were examined by naked eye for signs of abrasions/damage/gouges/ or anything that would indicate sloughing of metal material to cause shards.None were observed with naked eye.As an additional measure the needle and cutter were examined under microvu at high resolution magnification.No signs of abrasions/damage/gouges/ or anything that would indicate sloughing of metal material to cause shards.The most probable root cause was not found to be related to the mammotome device.

• Brand Name: MAMMOTOME REVOLVE
• Common Device Name: STEREOTACTIC PROBE - NON-GLASS FALCON - 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: 21287177
• Report Number: 3008492462-2025-00004
• Device Sequence Number: 12720350
• Product Code: KNW
• UDI-Device Identifier: 00841911102731
• UDI-Public: (01)00841911102731(10)F12436506D(17)270911
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152989
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MST1012
• Device Catalogue Number: CA000399017
• Device Lot Number: F12436506D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown