MAUDE Adverse Event Report: HOLOGIC, INC. CELERO-12; INSTRUMENT, BIOPSY

Model Number CELERO-12

Device Problems Product Quality Problem (1506); Failure to Obtain Sample (2533); Difficult to Open or Close (2921)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Biopsy device not working.The open and close process to engage the spring loaded biopsy action is not setting.This is the 2nd event in 1 week.Device is a celerobiopsy device ref.Celero-12, lot #22c21ra.

• Brand Name: CELERO-12
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 15833541
• MDR Text Key: 304016750
• Report Number: 15833541
• 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: 11/11/2022,11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CELERO-12
• Device Catalogue Number: CELERO-12
• Device Lot Number: 22C21RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2022
• Date Report to Manufacturer: 11/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1