MAUDE Adverse Event Report: A-DEC, INC. CASCADE; DELIVERY SYSTEM

Model Number 1040

Device Problem Installation-Related Problem (2965)

Patient Problem Bruise/Contusion (1754)

Event Date 04/16/2015

Event Type  Injury  

Event Description

In the course of dental treatment, an unauthorized mount holding a cascade delivery system broke and the assistant bruised her wrist.The assistant was conducting dental treatment on a patient in a cascade chair.The chair-mounted cascade delivery system fell suddenly towards the patient without warning.The assistant grabbed the delivery system, slowing its fall.The patient was not injured.The assistant received medical treatment (bandage) for a bruised wrist.The chair and delivery system were installed in 1995 by dental products services (b)(4) (an a-dec dealer at the time) using an unauthorized chair mount (not the design or manufacture of a-dec, installed without a-dec's knowledge).Root cause analysis shows the chair mount casting failed (broke suddenly by overloading or fatigue or both).Dental products services (b)(4) is no longer an a-dec dealer.Dates: equipment installed using unauthorized chair mount: 1995.Event occurred: (b)(6) 2015.A-dec initially made aware but details unavailable: (b)(6) 2015.A-dec collected last of detailed information: (b)(6) 2015.(b)(4).

Manufacturer Narrative

Dental products services (b)(4) installed an unauthorized mount and is no longer an a-dec dealer.

• Brand Name: CASCADE
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): A-DEC, INC.; 2601 crestview dr.; newberg OR 97132 925
• Manufacturer Contact: robert napora ; 2601 crestview dr.; newberg, OR 97132-9257 ; 5035389471
• MDR Report Key: 4795503
• MDR Text Key: 5816909
• Report Number: 3015729-2015-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention