MAUDE Adverse Event Report: MAMMOTOME HOLSTER

Model Number MSTH1001042

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/12/2016

Event Type  malfunction  

Event Description

During a stereo needle biopsy of the breast, the holster attached to the vacuum device did not function properly.

• Brand Name: MAMMOTOME HOLSTER
• Type of Device: MAMMOTOME HOLSTER
• MDR Report Key: 5728738
• MDR Text Key: 47508491
• Report Number: MW5062889
• Device Sequence Number: 1
• Product Code: IZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSTH1001042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR