MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE 100; INSTRUMENT, BIOPSY

Model Number	ATEC SAPPHIRE 100
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
It was reported that during an atec procedure on (b)(6) 2024, during the biopsy the equipment stopped sampling so they changed everything and they couldn´t do anything but power up.A second atec console was used and the biopsy was able to be completed.A second incision was required.No adverse effects or additional treatment was required.
Additional Manufacturer Narrative
Investigation was performed related to the case.Initial evaluation: the affected atec sapphire 100 system was shipped to the customer on (b)(6) 2022 and subsequently installed on (b)(6) 2022.There are no cases or complaints logged against the system for footswitch related issues prior to (b)(4).Therefore, it can be assumed that the footswitch that was in use at the time of the reported event was the original footswitch.This means that the footswitch had been in use for 652 days prior to the reported event.The system was not returned to hologic¿s post market quality assurance (pmqa) team for investigation but was instead sent to hologic¿s (b)(6) location to be serviced by a hologic manufacturing technician.Investigation methods and findings: the technician¿s investigation discovered that the footswitch was working intermittently due to a broken wire within the footswitch cable.Of note, the footswitch aids in activating ¿biopsy¿ and ¿manual aspiration¿ modes (more details can be found in the atec sapphire 100/200 service manual.The footswitch was replaced, and a preventative maintenance procedure was carried out.The console was subsequently calibrated and passed all testing.Cause/root cause: based on the investigation performed by the manufacturing technician, the cause of the reported issue can be linked to a broken wire within the cable for the electronic footswitch.A deeper dive into the root cause of the damaged/broken wire damage was unable to be performed as the footswitch was disposed of and not returned to the pmqa team.Conclusion: based on the investigation performed by the manufacturing technician, the cause of the reported issue can be linked to a broken wire within the cable for the electronic footswitch; however, because the cable was not returned to pmqa, a deeper dive into a specific root cause was unable to be performed.Future occurrences will continue to be monitored and trended.Complaint confirmed: yes.Date of manufacture: 2022-06-02.Date of installation: (b)(6) 2022.Date of last pm: suggested pm date set as (b)(6) 2024 (not performed).Unit was swapped before work order for pm fulfilled.System serial number: (b)(6).Unique device identifier (udi) information: (b)(4).

• Brand Name: ATEC SAPPHIRE 100
• Common Device Name: 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 park zone b24; san jose 20102
• MDR Report Key: 19735120
• Report Number: 1222780-2024-00232
• Device Sequence Number: 15484447
• Product Code: KNW
• UDI-Device Identifier: 15420045504028
• UDI-Public: (01)15420045504028(11)220602
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE 100
• Device Catalogue Number: ATEC SAPPHIRE 100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown