MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOTOME REVOLVE ST HOLSTER; BIOPSY INSTRUMENT

Model Number	MSTH1
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/29/2023
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, the event occurred before breast biopsy procedure.Before the piercing, a 505 error occurred and the holster disarmed.The probe needle advanced slowly, and needle was inserted into the patient's breast.The customer requested an investigation into this event.Procedure was completed with device.The customer reported no patient complications.To date, return of the device has been requested to further evaluate any other potential root causes.Devicor is the design owner of this device and responsible for investigation.Plexus is the legal manufacturer for this device.
Event or Problem Description
According to the reporter, the event occurred before breast biopsy procedure.Before the piercing, a 505 error occurred and the holster disarmed.The probe needle advanced slowly, and needle was inserted into the patient's breast.The customer requested an investigation into this event.Procedure was completed with device.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.The customer reports before the procedure began, a probe was installed on the msth1 holster and subsequently it was armed, retracting the probe's needle with a spring-loaded mechanism for rapid advancement into the desired tissue to be acquired.After arming the holster, an interruption of power to the holster occurred indicated by pop-up notification on the screen (505 error, 5v isolated voltage rail is out of tolerance).After power had been restored to the holster, the needle was "disarmed" slowly advancing the needle through motorized gear drive mechanism.The needle advanced into the patient's breast before the medical staff was prepared for this to occur.An investigation has revealed that the process of initializing the probe can move the probe's magnet out of detection proximity from the holster's integrated circuit chip (ic) purposed as sensor for detecting a probe's connection to the holster.If the holster experiences an event, such as a loss of power, upon reboot, and holster does not detect a probe because the magnet is beyond the holster sensor's field of sensitivity.If the holster does not detect a probe and is in an "armed state" prior to the loss of power, the mscm1 control module will automatically advance the needle or "disarm" to render it in a state that a new probe can be installed.This disarming process advances the needle slowly via the motor driven system as opposed to the rapid advancement, or firing, using the spring-loaded mechanism.Although there was no serious injury as a result of this event, we are submitting this report due to the potential of harm to a patient.
Event or Problem Description
According to the reporter, the event occurred before breast biopsy procedure.Before the piercing, a 505 error occurred and the holster disarmed.The probe needle advanced slowly, and needle was inserted into the patient's breast.The customer requested an investigation into this event.Procedure was completed with device.The customer reported no patient complications.
Additional Manufacturer Narrative
Initial report was submitted 27-dec-2023.Follow up #1 with device evaluation report was submitted 11-jan-2024.The purpose of this follow up report (follow up #2) is to correct/clarify follow up #1 with device evaluation report previously submitted.The information in follow up #1 with device evaluation report was correct but should have only had the following cells completed: b4 "date of this report", d2 "unique identifier #", g6 "type of report", g8 "manufacturer report number", h3 "device evaluated by manufacturer?", h6 "adverse event problem": type of investigation, investigation findings and investigation conclusions codes.Follow up #1 with device evaluation report had cell h2 "if follow up, what type?" blank.H2 should have had device evaluation checked off.In addition, h10 additional manufacturer narrative did not include that the product code msth1 does not have an expiration date assigned to it, therefore, d4 "expiration date" was left blank.
Additional Manufacturer Narrative
The initial report was submitted on 27-dec-2023.The purpose of this follow up report (#3) is to correct the initial report h5 'labeled for single use?' which was answered "yes" but should be "no".

• Brand Name: MAMMOTOME REVOLVE ST HOLSTER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): PLEXUS CORP.; 2400 millbrook dr; buffalo grove IL 60089
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 18397861
• Report Number: 3008492462-2023-00013
• Device Sequence Number: 2772587
• Product Code: KNW
• UDI-Device Identifier: 00841911100706
• UDI-Public: 00841911100706
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 06/04/2024

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 Model Number: MSTH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023; Not provided; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/11/2024; 05/22/2024; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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