MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS MAMMOTOME STEREOTACTIC PROBE; INSTRUMENT, BIOPSY

Model Number MST0812

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Suction connection on the mammotome stereotactic probe cracked/broke during procedure.The setup did pass initial testing.Fda safety report id # (b)(4).

• Brand Name: MAMMOTOME STEREOTACTIC PROBE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS ; cincinnati OH 45241
• MDR Report Key: 11723602
• MDR Text Key: 247577138
• Report Number: MW5100974
• Device Sequence Number: 1
• Product Code: KNW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MST0812
• Device Catalogue Number: MST0812
• Device Lot Number: F12110302D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR