MAUDE Adverse Event Report: HOLOGIC, INC SERTERA BIOPSY DEVICE; INSTRUMENT, BIOPSY

Model Number SERTERA-14

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/07/2023

Event Type  malfunction  

Event Description

It was reported that during a sertera procedure on march 7th, the physician pre-tested the needle before using it on the patient and the needle disconnected and discharged while in the physician´s hand.No patient or staff injury reported.No additional information.

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

• Brand Name: SERTERA BIOPSY DEVICE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 16611840
• MDR Text Key: 312409243
• Report Number: 1222780-2023-00089
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045504066
• UDI-Public: (01)15420045504066(17)241128810)E22L29RL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERTERA-14
• Device Catalogue Number: SERTERA-14
• Device Lot Number: E22L29RL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1