MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH; AIRWAY DEVICE CLEANING BRUSH, INVASIVE

Catalog Number 7204

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Investigation: the inspection of the brush was done under a microscope.All parts of the brush are available for investigation.The complaint report states that there was no harm to the user.Therefore we conclude that no medical intervention was required.The wire of the brush-head is broken.The bristles of the device are heavily worn (photos are available at the manufacturer).The bristles are destroyed and lying down, and have not been suitable to perform their function for some time.This indicates that the brush has been used for a longer period of time.Both of the twisted steel wires are broken, almost at the same place.No deformations or clamp marks that could have caused the breakage was found.This indicates that the breakage is not due to any failure in the wire material since the twisted wire is made of stainless steel and unlikely to break at same place.However, it is possible to break the wire if the brush head is bent back and forth at least 10 times (we tried to break of the head of 4 new brushes by bending it back and forth and it took 13 movements on average).The pp-plastic of the handle is deformed around the metal wire.This is not the case for a new brush and this also indicates that the brush head was bent.In the ifu for provox brush there is a warning picture showing that bending the brush head is prohibited.Conclusion of investigation: no material failure was found.The twisted metal wires of the brush have been broken off at same place.This cannot happen unless the wire was bent several times.The ifu states that it is prohibited to bend the brush on the metal wire.The damage to the product is most likely caused by wrong handling of the product and use beyond its expected lifetime.Reporting: during the initial assessment the complaint was classified as not reportable to authorities.This assessment was based on the fact the event was solely a result of use error, according to §2.6 medical device reporting for manufacturers issued nov 8, 2016.After investigation and searches in the internal complaint database it showed that broken tip has previously been aspirated by a patient and medical intervention was require to remove the tip from the lung.With this knowledge it was decided to report this event despite the fact there was no harm to the patient in this case.As a consequence, this event is reported outside the set time frame for reporting to authorities.This is an initial and final report in one.

Event Description

This is the information that was received from the initial reporter: according to customers in the normal, regular cleaning of the voice prosthesis - breaking off of the brush head.No damage to the customer! lot incomprehensible.Description of the product: provox brush is a device intended for cleaning of provox voice prosthesis in-situ.Cleaning is recommended twice a day and after each meal.

• Brand Name: PROVOX BRUSH
• Type of Device: AIRWAY DEVICE CLEANING BRUSH, INVASIVE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; hörby, 24222 ; SW 24222
• Manufacturer (Section G): ATOS MEDICAL AB; kraftgatan 8; hörby,
• Manufacturer Contact: karolina nilsson ; kraftgatan 8; hörby, 24222 ; SW 24222
• MDR Report Key: 7832494
• MDR Text Key: 118752568
• Report Number: 8032044-2018-00002
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 7331791000775
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/11/2018

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/30/2018
• 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