MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC 8G MAMMOTOME REVOLVE EX PROBE (9CM)

Model Number	MHEX08S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporter, they encountered denser tissue, and doctors felt the needle was not advancing smoothly.Despite considerable effort, it remained stuck, causing an accidental cut to the patient's skin.After the surgery was completed and the nurse applied pressure to stop the bleeding, the wound became smaller, so the doctor only needed to stitch it a few times and then finished.Procedure was completed with device.The mammotome revolve ex probes are sterile, single use devices, indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.Investigation pending.In attempts to receive the original device involved in the incident, customer responded on february 26, 2024 ".The one used on-site has been disposed of due to blood contamination".
Event or Problem Description
According to the reporter, they encountered denser tissue, and doctors felt the needle was not advancing smoothly.Despite considerable effort, it remained stuck, causing an accidental cut to the patient's skin.After the surgery was completed and the nurse applied pressure to stop the bleeding, the wound became smaller, so the doctor only needed to stitch it a few times and then finished.Procedure was completed with device.
Additional Manufacturer Narrative
The customer did not return a device to be investigated against the alleged complaint, however, 30 needles were imaged under high resolution microscope as a replacement investigation to determine if there were abnormalities found.No unusual blemishes were found that would lead to a high insertion force of the needle.Given the investigation findings and information available at this time, the alleged failure does not appear to be attributed to the device.The root cause is undetermined, however, possible root causes could be the needle tip is dull, difficulty with force to penetrate due to holster/probe size or user preference.The instructions for use (ifu) states that "once the device is armed (the "engaged" message appears on the touchscreen interface), the probe may be inserted into the percutaneous site by following one of two methods: the "pierce" method or the "push-in" method.Note: take care to avoid the needle tip during this procedure.Failure to follow this instruction could lead to patient or operator injury." in addition to providing investigation findings, this report is being submitted to correct the b codes in the initial report submitted 06-mar-2024.The codes should have been 4104 and 4115 as shown in this follow up #1 report.

• Brand Name: 8G MAMMOTOME REVOLVE EX PROBE (9CM)
• Common Device Name: REVOLVE EX
• 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, mx 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 18847622
• Report Number: 3008492462-2024-00004
• Device Sequence Number: 15393177
• Product Code: KNW
• UDI-Device Identifier: 00841911102342
• UDI-Public: (01)00841911102342(17)250524(10)F12220388D
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K033700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 05/24/2025
• Device Model Number: MHEX08S
• Device Lot Number: F12220388D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2022
• 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