MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA_0913-20; INSTRUMENT, BIOPSY

Model Number EVIVA_0913-20

Device Problems Difficult to Open or Close (2921); Mechanics Altered (2984); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

During a stereotactic breast biopsy the needle would not turn to take the second sample.The needle did obtain the first sample with no problem, but during the second sample, it stopped working--losing suction and does not open/close.The system would not stay in the ready status during the procedure.Biomedical engineering team inspected biopsy breast system and inspected the user connections and these appeared fine.Confirmed that the system would not come to ready status.Connected the biomed biopsy test needle per procedure and device came to ready status.Repeated procedure with user test needle and system would repeatedly not come to ready status.Performed test again with biomed test needle the system functions as intended with ready status.Advised user to replace the current needle as it appears to be the point of failure.Returned to service.We would like to return these needles to hologic for an investigation into failure.

Event Description

During a stereotactic breast biopsy the needle would not turn to take the second sample.The needle did obtain the first sample with no problem, but during the second sample, it stopped working--losing suction and does not open/close.The system would not stay in the ready status during the procedure.Biomedical engineering team inspected biopsy breast system and inspected the user connections and these appeared fine.Confirmed that the system would not come to ready status.Connected the biomed biopsy test needle per procedure and device came to ready status.Repeated procedure with user test needle and system would repeatedly not come to ready status.Performed test again with biomed test needle the system functions as intended with ready status.Advised user to replace the current needle as it appears to be the point of failure.Returned to service.We would like to return these needles to hologic for an investigation into failure.

• Brand Name: EVIVA_0913-20
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 15484740
• MDR Text Key: 300571341
• Report Number: 15484740
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVIVA_0913-20
• Device Catalogue Number: EVIVA_0913-20
• Device Lot Number: G22E04RD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Female