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

Model Number CAPTUS 3000

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Capintec has contracted with two outside firms, hamel engineering sciences, inc.And industrial testing laboratory services, llc , for static, dynamic and metallurgical studies.To date, the reports have been inconclusive in determining root cause.Additional testing is in process.

Event Description

While performing routine quality assurance testing on the capinte captus 3000 thyroid uptake system, a component in the spring arm (tension rod) broke causing the arm with the collimator to fall downward to its lowest point of travel, which is approximately 25 inches from the ground.The collimator and arm weigh 45 pounds, and could cause an injury if it hits a patient or operator.In this case, no patient was involved, and no injury occurred.

• Brand Name: CAPTUS 3000
• Type of Device: THYROID UPTAKE SYSTEM
• Manufacturer (Section D): CAPINTEC, INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): 2518443; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: mary yusko ; 620 alpha drive; pittsburgh, PA 15238 ; 4129631988
• MDR Report Key: 5398253
• MDR Text Key: 37728200
• Report Number: 2518443-2016-00001
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nuclear Medicine Technologist
• Device Model Number: CAPTUS 3000
• Device Catalogue Number: 5430-0077
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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