MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE; BIOPSY SYSTEM

Model Number ATEC SAPPHIRE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, an atec sapphire procedure was performed, the physician received a retest handpiece error and only 1 specimen was retrieved.The procedure has to be rescheduled due to equipment malfunction.No other information is available.

Manufacturer Narrative

Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based on the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.The serial number of the device was provided by the complainant, but at the moment the information is not available, therefore, the udi, expiration date, and manufacturing date are not known.When the information is received, hologic will submit a follow up with the information.A device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Field engineer tested the actual device, found the main pressure line was leaking, and repaired the main pressure line.Tested system operation and the system was functioning within hologic specifications.If additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

• Brand Name: ATEC SAPPHIRE
• Type of Device: BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15889844
• MDR Text Key: 307777932
• Report Number: 1222780-2022-00374
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATEC SAPPHIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female