MAUDE Adverse Event Report: COOK COOK - KOPAN'S BREAST LESION LOCALIZATION NEEDLE; HOOKWIRE

Model Number G02601

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Breast hook wire placed per radiologist.When moved to operating room, and dressing removed, hookwire was not exiting the skin as usual.Hookwire usually is exposed externally with a length of 3-4 inches.Physician (surgeon) had to manually locate hook wire.Hook wire used: 20 gauge / 7 cm 20 cm long.

• Brand Name: COOK - KOPAN'S BREAST LESION LOCALIZATION NEEDLE
• Type of Device: HOOKWIRE
• Manufacturer (Section D): COOK; bloomington IN
• MDR Report Key: 4387189
• MDR Text Key: 16089282
• Report Number: MW5039959
• Device Sequence Number: 1
• Product Code: KNW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G02601
• Device Catalogue Number: DKBL-20-7.0-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 101