MAUDE Adverse Event Report: HOLOGIC, INC ATEC 0914-20MR; INSTRUMENT, BIOPSY

Model Number	ATEC 0914-20MR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plastic sheath an atec device gets stuck to the patient's skin and tissue, requiring a larger skin incision.It is reported that the end of the sheath does not seem smooth.No further information is currently available.
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that the plastic sheath an atec device gets stuck to the patient's skin and tissue, requiring a larger skin incision.It is reported that the end of the sheath does not seem smooth.No further information is currently available.The device was not returned for this complaint, and only limited patient-related information was provided.Therefore, a full investigation could not be conducted.Without the returned sample, it is not possible to confirm a definitive root cause of the issue.Root cause analysis did not identify a definitive root cause.The investigation included a comprehensive review of complaint data and risk assessments, but could not perform any testing procedures, because the device was not returned.Conclusion: the reported issue could not be confirmed because the device was not returned.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr review was not conducted since the lot/serial number was not provided by the complainant.

• Brand Name: ATEC 0914-20MR
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23632864
• Report Number: 1222780-2025-00598
• Device Sequence Number: 13357308
• Product Code: KNW
• UDI-Device Identifier: 15420045504899
• UDI-Public: 15420045504899
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/29/2025

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 0914-20MR
• Device Catalogue Number: ATEC 0914-20MR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown