MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC 10G X 9CM MAMMOTOME REVOLVE STEROTACTIC PROBE; BIOPSY DEVICE

Model Number	MST1009
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/17/2018
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.The device has not been returned for evaluation, which prevents a full investigation and analysis of the root cause at this time.However, this failure mode has been identified in the risk management file for potential patient or user issue.The device is intended to be used by a trained professional who is familiar with the potential patient or user injury that could occur depending upon the environment and situation caused by this failure mode.Follow up medical intervention may be necessary if injury has occured.This failure mode has been evaluated by our medical advisor and based on potential for patient or user issue, it has been determined to be a reportable malfunction.Thus, pursuant to 21 cfr 803, we are submitting this medwatch report.
Event or Problem Description
It was reported by the sales person that the probe does not physically present any defect, but when connecting it to the holster the probe produces a vacuum error and will not produce a vacuum.The vacuum error is presented randomly.Procedure was completed with device.Patient had a hematoma.Surgical stitches were applied.

• Brand Name: 10G X 9CM MAMMOTOME REVOLVE STEROTACTIC PROBE
• Common Device Name: BIOPSY DEVICE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7858654
• Report Number: 3008492462-2018-00065
• Device Sequence Number: 19345405
• Product Code: KNW
• UDI-Device Identifier: 00841911100744
• UDI-Public: (01)00841911100744(17)210503(10)F11818307D
• Combination Product (Y/N): N
• PMA/510(K) Number: K152989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 05/03/2021
• Device Model Number: MST1009
• Device Catalogue Number: MST1009
• Device Lot Number: F11818307D
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other