MAUDE Adverse Event Report: CAPINTEC, INC. CAPTUS 3000; THYROID UPTAKE SYSTEM

Model Number CAPTUS 3000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Swelling (2091)

Event Date 12/11/2013

Event Type  malfunction  

Event Description

Technologist reported that she was positioning the collimator, which houses the detector of the captus 3000, over the pt's leg to perform a measurement.The collimator detached from the arm, and hit the pt near the knee area.The signal, cable remained attached.The pt experienced swelling, was treated with ice an sent to the ed for eval.X-rays were negative for fracture, and the pt was sent home.

Manufacturer Narrative

History of the system involved in the complaint.On (b)(6) 2011, the system was upgraded at the customer's request to a captus 3000 (cnv 712).Because the system was more than 10 years old, the upgrade included a new collimator receptacle, captive spring plunger and snap ring, which together support the collimator.All of these components were installed by the customer's biomedical engineering department.On (b)(6) 2012, customer purchased another collimator receptacle, captive spring plunger and snap ring, as well as two kinds located on the collimator receptacle.On (b)(6) 2012, customer purchased two knobs located on the spring arm.On (b)(6) 2013, someone from the customer's biomedical engineering department called stating unit indicated wear.At that time, customer ordered another collimator, collimator receptacle, and captive spring plunger.On (b)(6) 2013, customer ordered another four plastic knobs.On (b)(6) 2013, customer ordered detector signal cable.On (b)(6) 2013, (b)(4), customer's chief technologist, called to report the above incident.Note: capintec has requested return of suspect device on multiple occasions, but has not yet received it.Therefore, complete eval and failure analysis cannot be performed unless/until the device is returned.

• Brand Name: CAPTUS 3000
• Type of Device: THYROID UPTAKE SYSTEM
• Manufacturer (Section D): CAPINTEC, INC.; 6 arrow drive; ramsey NJ 07446
• Manufacturer (Section G): CAPINTEC, INC.; 620 alpha dr.; pittsburgh PA 15238
• Manufacturer Contact: mary yusko ; 620 alpha dr.; pittsburgh, PA 15238 ; 4129631988
• MDR Report Key: 3650489
• MDR Text Key: 4351927
• Report Number: 2518443-2013-00001
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nuclear Medicine Technologist
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAPTUS 3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR