MAUDE Adverse Event Report: HOLOGIC, INC. SECURMARK FOR ATEC; INSTRUMENT, BIOPSY

Catalog Number SMARK-A1312-SS2

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2017

Event Type  malfunction  

Event Description

Select a product family: atec biopsy site markers.Device part number: smark-a1312-ss2.Quantity of product possibly defective : 1.Us technologist states "clip did not deploy".

• Brand Name: SECURMARK FOR ATEC
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 6449136
• MDR Text Key: 71376571
• Report Number: 6449136
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/17/2017
• Device Catalogue Number: SMARK-A1312-SS2
• Device Lot Number: 1605097A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 68