MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC 8G X 12 MAMMOTOME STEREOTACTIC PROBE; BIOPSY SYSTEM,

Model Number MST0812

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

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 reviewed by our medical advisor and identified in the risk management file for performance expectations.The device is intended to be used by a trained professional who is familiar with precautions related to blood borne pathogen exposure when completing a biopsy procedure.However, ejection with velocity is not expected by the user and has greater chance to harm than fluid egression including, but not limited to, the fluid entering mucous membranes.The device is not meeting its intended performance specification and claims and is considered to have malfunctioned.The patient or user may be exposed to biological hazards resulting in infection or cross-contamination.Although no serious injuries have occured, this failure mode has been evaluated by our medical advisor and based on potential for cross contamination or infection due to possible exposure to body fluids, it has been determined to be a reportable malfunction.Thus, pursuant to 21 cfr 803, we are submitted this medwatch report.

Event Description

It was reported by the sales representative, the customer had 3 times lately where blood/fluid "shot/sprayed out" the back of the specimen chamber during a procedure.Procedure was completed with the original device.No patient complication.

• Brand Name: 8G X 12 MAMMOTOME STEREOTACTIC PROBE
• Type of Device: BIOPSY SYSTEM,
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEDICAL; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7754360
• MDR Text Key: 116863284
• Report Number: 3008492462-2018-00053
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00841911100720
• UDI-Public: (01)00841911100720(17)210502(10)F11817453D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2021
• Device Model Number: MST0812
• Device Catalogue Number: MST0812
• Device Lot Number: F11817453D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1