MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH

Catalog Number 7204

Device Problems Break (1069); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation: inspection was done visually in microscope.The steel wire was broken and the twisted wires are both broken almost at the same place.This indicates that this is not due to material weakening since the twisted wire is made of stainless steel and unlikely to break at the same place.There is no material error found on the brush.It is possible to break the wire if the brush head is bent back and forwards a couple of times, therefore there is a warning according in the manual showing that bending the brush head is not allowed.Conclusion: the twisted metal wires of the brush have been broken off at same place and this can only happen if the wire was bent several times.According to manual it not allowed to bend the brush on the metal wire.Conclusion is that there is no product fault and therefore the breakage has to be caused by wrong handling of the product.

Event Description

The brush broke during cleaning of the prosthesis.The brush head was stuck in the prosthesis so the doctor had to remove it with a forceps.

• Brand Name: PROVOX BRUSH
• Type of Device: BRUSH
• Manufacturer (Section D): ATOS MEDICAL AB; po box 183; kraftgatan 8; horby, SE-24 2 22; SW SE-242 22
• Manufacturer (Section G): ATOS MEDICAL AB; po box 183; kraftgatan 8; horby, SE-24 2 22; SW SE-242 22
• Manufacturer Contact: ferenc dahner ; po-box 183; horby, SE-24-2 22 ; SW SE-242 22 ; 6 415 1980
• MDR Report Key: 5250470
• MDR Text Key: 32343143
• Report Number: 8032044-2015-00008
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• 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): Required Intervention