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

Model Number	MHUS08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
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.The procedure time was lengthened one hour and there was repeated cut that caused wound.The customer reported no patient complications.To date, return of the device has been requested to further evaluate any other 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.The procedure time was lengthened one hour and there was repeated cut that caused wound.The customer reported no patient complications.
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.The procedure time was lengthened one hour and there was repeated cut that caused wound.The customer reported no patient complications.The mhus08 device was returned for evaluation and conformed to specifications.The instructions for use (ifu) indicate that "the u/s probe (with its integrated components) is a sterile, single-patient-use device that may be used with imaging guidance to excise a tissue sample for diagnosis" and "steps for tissue sampling note: ensure that the patient and probe are in the correct location for tissue biopsy".A copy of the ifu was sent to the customer.Based on the details of how the event occurred and information provided in the ifu it was determined that this event did not occur as a result of a device malfunction.
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.The procedure time was lengthened one hour and there was repeated cut that caused wound.The customer reported no patient complications.
Additional Manufacturer Narrative
The initial report was submitted on 26-oct-2023.The purpose of this follow up report (follow-up #2 with corrections) is to correct/clarify initial and follow up reports previously submitted.Corrections that should have been applied to initial report: d5 "operator of device" and h5 "labeled for single use" left blank and were updated in this follow up #2 report.Corrections that should have been applied to follow up #1: h2 "if follow up, what type?" should have "device evaluation" checked off only.Since this was a follow-up (device evaluation), the report should have only contained new information in cells: b4 "date of this report", d9 "device available for evaluation", g6 "type of report", g8 "manufacturer report number", h2 "if follow up, what type?", h3 "device evaluated by manufacturer", h6 "adverse event problem" with updated investigation codes (type of investigation, investigation findings and investigation conclusions codes) only, h10 "additional manufacturer narrative" with updated new information only.

• Brand Name: MAMMOTOME REVOLVE ULTRASOUND PROBE
• 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: ms. boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 18012473
• Report Number: 3008492462-2023-00011
• Device Sequence Number: 17989194
• Product Code: KNW
• UDI-Device Identifier: 10841911102752
• UDI-Public: (01)10841911102752(17)260508(10)F12318301D
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2024

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 Expiration Date: 05/08/2026
• Device Model Number: MHUS08
• Device Lot Number: F12318301D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2023
• Supplement Date Received by Manufacturer: 09/30/2023; Not provided
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/04/2023; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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