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

Model Number	EVIVA 0913-12
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The hologic biopsy probe, eviva standard 9g did not function when we had the patient in position prone on the table ready for biopsy.We had to delay the start of the biopsy while we exchanged the defective probe for one that worked properly.This extended the length of time the patient was prone and compression.

• Brand Name: EVIVA
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 7863664
• Report Number: 7863664
• Device Sequence Number: 1678103
• Product Code: KNW
• UDI-Device Identifier: 15420045505322
• UDI-Public: (01)15420045505322
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/06/2018
• Report Date (Section F): 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVIVA 0913-12
• Device Catalogue Number: EVIVA 0913-12
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/06/2018