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

Model Number	MST1012
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the event occurred during the procedure there was an incident of foreign body of unknown origin in relation to this equipment.This has resulted in this equipment being removed from clinical use with immediate effect.Client attended (b)(6)2025 for an initial 14g biopsy (handheld biopsy device).An ultraclip marker was inserted during this procedure.The pathology results were b1 so a further biopsy was arranged for this morning.This repeat biopsy was performed with 10g needle on the mammotome vacuum assisted biopsy equipment.4 cores were taken and upon x-ray examination of these a foreign body was discovered within the core.This has a corkscrew appearance and is not of the same size or shape as the ultraclip marker that was already in situ from previous biopsy.The entire mammotome needle system was removed from the patient and a hydromark clip was deployed (this is a different size and shape from ultraclip to allow us to differentiate between the 2 clips).Post clip x-rays were taken and both markers are seen fully intact on the image.From analysis of the initial x-rays, there was no previous metal work in the client's breast that could account for this being removed with the biopsy sample.We checked the specimen cabinet and there was no debris in the specimen cabinet tray that would account for this.The affected probe was quarantined in a sharps safe container.
Additional Manufacturer Narrative
According to the reporter, the event occurred during the procedure there was an incident of foreign body of unknown origin in relation to this equipment.This has resulted in this equipment being removed from clinical use with immediate effect.Client attended (b)(6)2025 for an initial 14g biopsy (handheld biopsy device).An ultraclip marker was inserted during this procedure.The pathology results were b1 so a further biopsy was arranged for this morning.This repeat biopsy was performed with 10g needle on the mammotome vacuum assisted biopsy equipment.4 cores were taken and upon x-ray examination of these a foreign body was discovered within the core.This has a corkscrew appearance and is not of the same size or shape as the ultraclip marker that was already in situ from previous biopsy.The entire mammotome needle system was removed from the patient and a hydromark clip was deployed (this is a different size and shape from ultraclip to allow us to differentiate between the 2 clips).Post clip x-rays were taken and both markers are seen fully intact on the image.From analysis of the initial x-rays, there was no previous metal work in the client's breast that could account for this being removed with the biopsy sample.We checked the specimen cabinet and there was no debris in the specimen cabinet tray that would account for this.The affected probe was quarantined in a sharps safe container.The mst1012 will not be returned.The investigation is pending the evaluation of the foreign material.
Additional Manufacturer Narrative
The foreign material was not returned.The mst1012 was returned for evaluation.It was noted that there was no missing metal (no gouges/abrasions found) on the probe.The cutter was damaged on the cutting edge but did not shed any visible metal based upon high resolution magnification.Root cause is undetermined but found to be unrelated to probe.

• 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: 21535769
• Report Number: 3008492462-2025-00010
• Device Sequence Number: 20587637
• Product Code: KNW
• UDI-Device Identifier: 00841911102731
• UDI-Public: (01)00841911102731(10)F12424404D(17)270617
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152989
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: MST1012
• Device Catalogue Number: CA000399017
• Device Lot Number: F12424404D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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