MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA; INSTRUMENT, BIOPSY

Model Number 0913-20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/29/2021

Event Type  malfunction  

Event Description

While performing a breast biopsy, after imaging the specimen, a small foreign body was seen on the x-ray.Additional imaging was taken of the pathology separated specimens.The doctor found a small piece of plastic looking material that was removed.The device used was saved along with the material found in the specimen.Hologic notified.

• Brand Name: EVIVA
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 13306585
• MDR Text Key: 284114500
• Report Number: 13306585
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0913-20
• Device Lot Number: 21L11RD
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Female
• Patient Ethnicity: Hispanic