MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC 10G X 9CM MAMMOTOME® REVOLVE STEREOTACTIC PROBE; BIOPSY SYSTEM

Model Number	MST1009
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 10g x 9cm mammotome® revolve stereotactic probe is a sterile, single patient use instrument which may be used with imaging guidance, such as x-ray, to excise a diagnostic sample for diagnosis.The device is not available to be returned to the manufacturer for evaluation, which prevents a full investigation and analysis of the root cause at this time.However, the failure more has been identified in the risk management file and has been shown to occur if the tissue strip contained in the sample management systems are not fully aligned or seated properly as instructed within the ifu.Although no serious injuries occured, upon consultation with devicor's medical department, this failure mode has been determined to be a reportable malfunction as a result of potential loss of tissue for diagnostic purpose.Thus, pursuant to 21 cfr 803, we are submitting this medwatch report.
Event or Problem Description
Troubleshooting in vab, no core in the tray.

• Brand Name: 10G X 9CM MAMMOTOME® REVOLVE STEREOTACTIC PROBE
• Common Device Name: BIOPSY SYSTEM
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7697707
• Report Number: 3008492462-2018-00052
• Device Sequence Number: 1121286
• Product Code: KNW
• UDI-Device Identifier: 10841911100741
• UDI-Public: (01)10841911100741(17)210423(10)F11815454D
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: MST1009
• Device Catalogue Number: MST1009
• Device Lot Number: F11815454D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/18/2018
• 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