MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC. MAMMOTOME BIOPSY SITE IDENTIFIER; CLIP, IMPLANTABLE

Model Number MAMMOMARK 11

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

During stereotactic breast biopsy, piece of insertion device for biopsy clip identifier broke off leaving plastic embedded at biopsy site.Abnabno.Fda safety report id# (b)(4).

• Brand Name: MAMMOTOME BIOPSY SITE IDENTIFIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC. ; cincinnati OH 45241
• MDR Report Key: 11214202
• MDR Text Key: 258705433
• Report Number: MW5098948
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: MAMMOMARK 11
• Device Catalogue Number: MAM3001
• Device Lot Number: UNK
• 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 Outcome(s): Other
• Patient Age: 54 YR