MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME REVOLVE STEREOTACTIC PROBE; BIOPSY SYSTEM

Model Number	MST1009
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	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The affiliate reported that after implanting a hydromark, there was a foreign object of a piece of metal other than the coil.According to the facility, it did not appear to be plunger shearing, but it did show an object of a piece of metal that was clearly a different shape than the open coil.Immediately the facility removed the foreign object from the patient's body.
Additional Manufacturer Narrative
The mammotome revolve dual vacuum assisted biopsy system is intended to obtain tissue samples from the breast or axillary nodes for diagnostic analysis of breast abnormalities.The affiliate reported that after implanting the hydromark, x-rays reveled a foreign object of a piece of metal other than the coil in the breast.According to the facility, it did not appear to be plunger shearing, but it did show an object of a piece of metal that was clearly a different shape than the open coil.Immediately the facility removed the foreign object from the patient's body.The device was returned for investigation.Upon investigation: the probe and marker were examined for obvious damage and none were found; the object was measured and was found to be ~.04" in diameter; the size of the object is similar in size to the deadstop in the needle.However, no definitive conclusions of where the object could have originated.Based on the investigation findings there is no evidence that the foreign material came from the device involved in this incident and there is no conclusive evidence the foreign material came from our manufacturing site.A review of the complaint database was performed and there were no other complaints reported against this lot number.Although there is no evidence of serious injury and no evidence of device malfunction, we are reporting this incident due to the allegation of malfunction and inconclusive investigation results.
Additional Manufacturer Narrative
The initial report was submitted on 03-mar-2023.The purpose of this follow up (#2) report is to correct information originally submitted in the intial report.G6 - should have had the "initial" box checked.D4- serial & lot number sections were corrected.The number was removed from serial number section and added to the lot number section.Note: the initial report also had the incorrect model # in d4 but this was corrected with follow up (#1) report which was submitted 30-aug-2023.H11 in the intial report had grammar errors and were corrected below.The mammotome revolve dual vacuum assisted biopsy system is intended to obtain tissue samples from the breast or axillary nodes for diagnostic analysis of breast abnormalities.The affiliate reported that after implanting the hydromark, x-rays revealed a foreign object of a piece of metal other than the coil in the breast.

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE
• Common Device Name: BIOPSY SYSTEM
• 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; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 16482158
• Report Number: 3008492462-2023-00004
• Device Sequence Number: 12045400
• Product Code: KNW
• UDI-Device Identifier: 00841911102724
• UDI-Public: (01)00841911102724(17)250607(10)F12222469D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2024

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 Expiration Date: 06/07/2025
• Device Model Number: MST1009
• Device Lot Number: F12222469D
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023; 02/07/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 08/30/2023; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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