MAUDE Adverse Event Report: PALISADES DENTAL, LLC IMPACT AIR 45; DENTAL HANDPIECE, PRODUCT CODE: EBF

Model Number 403

Device Problems Device Maintenance Issue (1379); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

On 10/17/2017 palisades dental, llc was notified by (b)(6) of an event that occured on (b)(6) 2017 and reportedly involved the use of an impact air 45 handpiece, #ia302574.The initial report stated, on "10/12/2017 (b)(6) received notice from (b)(6) at (b)(6), sr.Manager risk management and loss prevention that this event was reported to the fda as a voluntary report.The report states, 'patient was having a dental procedure completed when the bur came out of the handpiece and was swallowed'.On 10/17/2017 (b)(6) called office and spoke with (b)(6), office manager who said that the doctor using was performing an extraction procedure when a surgical bur, not providing any specifics of the bur came out and was swallowed.Since it was seen by doctor that the bur was swallowed they did not send the patient for an x-ray.As of today they have not yet heard from the patient." as part of palisades dental's investigation, on 10/17/2017 a review of palisades dental sales records confirmed the sale of #ia302574 on 04/09/2015 to (b)(6).Records further indicate that the handpiece has not been at palisades dental for service since it was originally sold.A review of manufacturing records for #ia302574 did not find any abnormalities with the batch records or associated documentation.On 10/23/2017 palisades dental received sus voluntary event report, report #mw5072757, filed by brian bay of aspen dental.The report relates to the alleged event date of (b)(6) 2017 involving an impact air 45 handpiece; however, the report does not reference a serial number.The report states: "patient was having a dental procedure completed when the bur came out of the handpiece and was swallowed." as part of palisades dental's investigation, on 11/08/2017 a representative of palisades dental called (b)(6) and spoke to the dentist who performed the procedure, a dental assistant who assisted with the procedure, and the office manager of (b)(6).When the palisades dental representative asked about the current condition of the patient, the office manager stated that there were no issues with the patient that she was aware of.When asked if the patient had undergone surgical intervention, the office manager stated, "no." the office manager further stated that the "patient was at the office for postop, everything seems ok." when asked if the handpiece had previously been sent for service, the office manager indicated that it had been sent to (b)(6), but she did not know when or for what service.Subsequently, the palisades dental representative spoke to the dentist who performed the procedure.The dentist confirmed that the date of the incident was, monday, (b)(6) 2017.The dentist stated that while removing a lower right tooth from a female patient the bur popped out of the handpiece, the doctor put it back in and pulled on it 3 times to ensure it was tight.The dentist began using the handpiece and the bur popped out again and fell to the back of the patient's mouth and was swallowed.The palisades dental representative asked if the patient had received medical treatment and the dentist answered, "no." the dentist indicated that the patient had a postop visit one week later and "seems fine" and as far as the dentist knows, the patient sustained no permanent damage.The palisades dental representative proceeded to speak to the dental assistant who assisted with the procedure.The dental assistant reported that the handpiece is used daily and is sent out for service to handpiece headquarters in (b)(4), a division of (b)(4).When asked what if anything is done to the handpiece unit after each use, the dental assistant stated that they, "wipe down the handpiece, lube it, bag it and sterilize it." the dental assistant further stated they do not take the handpiece apart for cleaning.On 11/10/2017 handpiece #ia302574 was received at palisades dental.When examining the handpiece, the following was found: head cap and turbine all have varying degrees of brown residue.The turbine assembly is a non-palisades dental part and includes: bearings that are dirty and non-palisades dental parts - worn o-rings and non-palisades dental part - 3 thin washers non-palisades dental parts (there should be two, one thin and one thick) - chuck is weak does not hold bur tightly it's teeth are very dirty.The inside of the spindle is also very dirty and doesn't allow the chuck to accept the bur; both the chuck and spindle are non-palisades dental parts.On 11/13/2017 palisades dental determined that the failure of handpiece #ia302574 is not manufacturer related, rather it is related to lack of routine maintenance, service that did not comply to manufacturer's recommendations, and/or the use of non-palisades dental parts - any or all of these factors contributed to the alleged failure.Palisades dental has determined that either use of non-palisades dental parts and/or lack of routine maintenance potentially contributed to the event.Palisades dental deems no action needed since the ifu provides cleaning instructions and instructs the user to return the device to palisades dental for evaluation and service.

Event Description

It was reported that on (b)(6) 2017 as a "patient was having a dental procedure completed when the bur came out of the handpiece and was swallowed.Since it was seen by doctor that the bur was swallowed they did not send the patient for an x-ray.As of today they have not yet heard from the patient".

• Brand Name: IMPACT AIR 45
• Type of Device: DENTAL HANDPIECE, PRODUCT CODE: EBF
• Manufacturer (Section D): PALISADES DENTAL, LLC; 111 cedar lane; englewood NJ 07631
• Manufacturer (Section G): PALISADES DENTAL, LLC; 111 cedar lane; englewood NJ 07631
• Manufacturer Contact: maureen mcgovern ; 111 cedar lane; englewood, NJ 07631 ; 2015690050
• MDR Report Key: 7038020
• MDR Text Key: 93320184
• Report Number: 3003963943-2017-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2017

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: Dentist
• Device Model Number: 403
• Device Lot Number: 7146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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): Other