MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES KAVO MULTIFLEX COUPLING 457; HANDPIECE, AIR-POWERED DENTAL

Model Number 0.553.1210

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

Considered by the fda to be a dental device/equipment and should be reprocessed if detachable.The kavo multiflex coupling 457-0.553.1210 is a detachable device, however the mfr has rendered this item non-sterilisable.Mfrs who state their couplers are not a medical device should be reported to the fda via their medwatch program.Equipment that can be removed from the dental unit lines should be cleaned and sterilized between each pt according to the mfr's validated ifu for the item.The cdc is not a regulatory agency and does not publish regulations or other legally enforceable standards.Cdc's role is to provide guidelines and recommendations related to infection prevention in dental health care settings and to provide overall guidance on infection prevention practices.These guidelines represent the minimum standard of practice recommended for safe care in all dental settings and are designed to prevent transmission of infectious agents among pts and dental health care personnel in dental settings.

• Brand Name: KAVO MULTIFLEX COUPLING 457
• Type of Device: HANDPIECE, AIR-POWERED DENTAL
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES; charlotte NC 28273
• MDR Report Key: 8470980
• MDR Text Key: 141025020
• Report Number: MW5085447
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2019

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: Health Professional
• Device Model Number: 0.553.1210
• Device Catalogue Number: 457
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1