MAUDE Adverse Event Report: CIVCO MEDICAL INSTRUMENTS CO., INC BRACHYSTEPPER EX3

Model Number 620-119LOAN

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

Unit was returned for investigation and service.Rotary encoder was found to report "failed error code" when connected to the computer.Replacing the encoder corrected the problem with the unit and returned the item to full operation.(b)(4).

Event Description

Civco was notified that the senior physicist from a user facility encountered a device failure in the course of preparing for a procedure.A routine check of the connection between the civco stepper and the variseed computer was carried out before the patient being anaesthetised.The stepper system worked correctly with no indications of any problem.Contouring of the prostate proceeded as per usual with no issues arising.The clinician stepped out to scrub up, then checked the seed calculation before returning to use the system - at this point an error message appeared on the variseed screen indicating that variseed was unable to connect to the tracked stepper.Attempts to rectify the problem failed.As a result of the failure one patient was anaesthetised unnecessarily and two implants were cancelled, two full sets of seeds were unused.The procedure was re-scheduled for a later time.No patient injuries were reported.

• Brand Name: BRACHYSTEPPER EX3
• Type of Device: STEPPER
• 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: 6543766
• MDR Text Key: 74607412
• Report Number: 1937223-2016-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K131161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/21/2016,10/21/2016

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: Health Professional
• Device Model Number: 620-119LOAN
• Device Catalogue Number: 620-119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other