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

Model Number 0914-20-OB

Device Problems Break (1069); Detachment Of Device Component (1104); Out-Of-Box Failure (2311)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Event problem and evaluation codes-results and conclusion: the device was received and visually inspected.The investigator verified that the obturator is broken.The reported observation was confirmed.This observation is being trended and monitored.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.Reference internal complaint: (b)(4).

Event Description

It was reported during a breast biopsy procedure on (b)(6) 2016, the obturator tip broke off inside the package.The tip did not break off inside the patient.No patient injury reported.

• 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: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5826600
• MDR Text Key: 51245019
• Report Number: 1222780-2016-00191
• Device Sequence Number: 1
• Product Code: GDF
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/02/2016
• Device Model Number: 0914-20-OB
• Device Catalogue Number: ILS 0914-20-OB
• Device Lot Number: 604557
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2016
• 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