MAUDE Adverse Event Report: CIVCO MEDICAL INSTRUMENTS CO., INC NEOGUARD COVER; ULTRASOUND COVER

Model Number 610-844

Device Problems Material Puncture/Hole (1504); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

Product was not returned, however photo's of the cover and probe were provided.From the photographs shown, the probe has a metalic cylindrical end which was which the user was able to push through the tip of the cover cutting a circular hole in the cover itself.This is a re-submission of the report conducted on 1/2/2017.Original submission had incorrect facility identification number and was rejected.

Event Description

The patient was undergoing a mastectomy / biopsy sentile node of the left breast.When the probe was placed on the sterile back table, it was noted that the tip of the probe (node seeker) had penetrated through the transducer cover.A small round piece of the transducer cover was later recovered on the sterile mayostand.The sterile field was taken down, tha patient was re-prepped and surgery was continued with a new draping and instruments.Surgical site was 2x irrigated with ns before closure.No patient injures or problems were reported.

• Brand Name: NEOGUARD COVER
• Type of Device: ULTRASOUND COVER
• Manufacturer (Section D): CIVCO MEDICAL INSTRUMENTS CO., INC; 102 first street south; kalona IA 52247
• Manufacturer (Section G): CIVCO MEDICAL INSTRUMENTS CO., INC.; 102 first street south; kalona IA 52247
• Manufacturer Contact: james leong ; 2301 jones blvd; coralville, IA 52241 ; 3192486502
• MDR Report Key: 6543763
• MDR Text Key: 74605253
• Report Number: 1937223-2017-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/01/2018
• Device Model Number: 610-844
• Device Catalogue Number: 610-844
• Device Lot Number: M745600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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