MAUDE Adverse Event Report: HOLOGIC, INC ATEC INTRODUCER LOCALIZATION SET SURESIGHT; SURGICAL NEEDLE GUIDE

Model Number 0914-20-OB

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.If additional relevant information is received, a supplemental medwatch will be filed.We are currently in the process of evaluating the device and will send a supplement report when completed.(b)(4).

Event Description

It was reported during an atec breast biopsy the suresight obturator was inserted into the grid.The tip "came off inside the patient's breast." we have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

The returned device was received and visually inspected.The investigator verified that the distal tip of the obturator is broken.Cause is presently unknown for failure.The reported observation was confirmed.This observation is being trended and monitored.

Event Description

On (b)(6) 2016, it was reported the patient went home and then later had a lumpectomy and the piece was removed.

• Brand Name: ATEC INTRODUCER LOCALIZATION SET SURESIGHT
• Type of Device: SURGICAL NEEDLE GUIDE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5496062
• MDR Text Key: 40442456
• Report Number: 1222780-2016-00056
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/18/2016
• Device Model Number: 0914-20-OB
• Device Catalogue Number: ILS 0914-20-OB
• Device Lot Number: 512503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1