MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME REVOLVE; BIOPSY INSTRUMENT

Model Number	MHUS08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
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.According to the reporter, during the procedure there was inadequate tissue or no tissue (no error code) and cutter stall.The procedure was completed with another device.A second incision was needed to complete the procedure.No medical treatment.Repeated cut caused wound.The procedure time was lengthened for about 15 minutes.The device was returned on 18-mar-2024 and will be further evaluated for potential root causes.
Event or Problem Description
According to the reporter, during the procedure there was inadequate tissue or no tissue (no error code) and cutter stall.The procedure was completed with another device.A second incision was needed to complete the procedure.No medical treatment.Repeated cut caused wound.The procedure time was lengthened for about 15 minutes.
Additional Manufacturer Narrative
The returned mhus08 device was returned and evaluated.A visual inspection of the cutter tube noted that there was a rolled/broken edge.All other tests and inspections were found to be conforming.The rolled edge was found on the inner cutter and the edge was damaged irregularly.The probe drive gear needed more resistance to rotate when testing it manually, but the probe could pass the initialization process on the system test (capital+ holster +vacuum set).System biopsy tests were completed successfully with the returned mhus08 device.The site issue could not be reproduced in the laboratory.Based on the available information, this event did not occur as a result of device malfunction and we were unable to determine a root cause for this complaint.A possible root cause for damage to inner cutter is hard tissue cutting which is related to the patient anatomy.If any new information is received, we will reevaluate and submit a follow up report to document any changes.
Additional Manufacturer Narrative
The initial report was submitted on 27-mar-2024.The purpose of this follow up #2 report is to correct the model # and catalog # in section d4 in the initial report.Model # was corrected to mhus08 and catalog # was corrected to ca000400003.In addition, the follow up #1 report with device evaluation had a grammar error in h11 manufacturer narrative which is corrected below: "if any new information is received, we will reevaluate and submit a follow up report to document any changes.".
Additional Manufacturer Narrative
The initial report was submitted on 27-mar-2024.Follow up 2 report was submitted on 15-apr-2024.The purpose of this follow up report 3 is to correct the following cells in the initial report: b1 should only have the adverse event box checked and g1 contact office - manufacturing site had the incorrect state abbreviation listed.The following is corrected for follow up 2 report: d4 catalog # and d4 model #.

• Brand Name: MAMMOTOME REVOLVE
• Common Device Name: BIOPSY INSTRUMENT
• 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, mex 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; sor juanaines de la cruz; #20152 4-b; tijuana, bc, OH 22440 ; MX 22440 ; 5138649047
• MDR Report Key: 18985814
• Report Number: 3008492462-2024-00005
• Device Sequence Number: 19550135
• Product Code: KNW
• UDI-Device Identifier: 00841911102755
• UDI-Public: (01)00841911102755(10)F12306516D(17)260215
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2025

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 Expiration Date: 02/15/2026
• Device Model Number: MHUS08
• Device Catalogue Number: CA000400003
• Device Lot Number: F12306516D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024; 02/26/2024; Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/05/2024; 04/15/2024; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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