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

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 03/23/2018

Event Type  Injury  

Manufacturer Narrative

On 16-may-2018 palisades dental, llc was notified by (b)(6) of an event that occurred on (b)(6) 2018 and reportedly involved the use of an impact air 45 handpiece, (b)(4).The initial report states, "the customer reports that during a surgical procedure a 557 type burr came out of the handpiece inside of a (b)(6) female patient's mouth.A chest x-ray was performed." (b)(6) included a copy of the medwatch voluntary report that was completed by (b)(6).The voluntary medwatch report states "burr came out during procedure", "chest x ray" was performed, and the date of the event is stated as (b)(6) 2018.As part of palisades dental's investigation, on 16-mar-2018 a review of palisades dental sales records confirmed the sale of (b)(4) on 25-feb-2010 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 (b)(4) did not find any abnormalities with the batch records or associated documentation.On 29-may-2018 palisades dental received sus voluntary event report, report #mw5077317 by mail, dated 17-may-2018, filed by (b)(6).The report states: "burr came out during procedure" and the event date is stated as (b)(6) 2018.As part of palisades dental's investigation, on 30-may-2018 palisades dental representatives called (b)(6) and spoke to the dental manager who followed up with the patient after the incident.When asked about the patient's current condition, the dental manager stated that she believes the patient is fine and that the patient sustained no permanent damage.After the bur came out of the handpiece, (b)(6) dental personnel strongly suggested that the patient go to the hospital for follow-up and the dental manager stated that the patient received intervention to remove the bur and that the bur was successfully removed.The dental manager further reported that the patient returned to the dental office for a follow-up dental visit and was fine.The palisades dental representatives proceeded to ask the dental manager about the cleaning and servicing of handpiece (b)(4).The dental manager reported that all handpieces at the (b)(6), including the handpiece involved in this incident, are sent to (b)(6), but the dental manager was not sure what type of service or how often they are serviced.When asked if anything is done to the handpiece after each use, she replied, "they are wiped them down and lube them and sterilize them, they are not taken apart." the dental manager further stated that the normal procedure is that the dental assistant would have inserted the bur in the handpiece, tugged on it, and then given it to the dentist.Subsequently, on 31-may-2018 palisades dental representatives spoke to the dentist who performed the procedure.The dentist confirmed that the date of the incident as (b)(6) 2018.The dentist stated that, "it was a routine extraction and during the extraction the bur was ejected from the handpiece." the dentist further reported that when the procedure was completed, and he ensured that the patient was stable, he asked the patient if she had felt she had swallowed the bur and the patient was not sure.The dentist and the dental manager escorted the patient to an office and insisted that she seek medical attention to determine the whereabouts of the bur.The dentist was not sure if patient received medical treatment and was not sure of the patient's current condition or if she sustained permanent damage.The dentist confirmed that the bur involved was a 557 surgical bur and that the dental assistant inserted it into the handpiece and tugged on it before handing it to him.The dentist further reported that he also tugged on the bur prior to use.On 22-may-2018 handpiece (b)(4) was received at palisades dental.When examining the handpiece, the following was found: the turbine assembly is a non-palisades dental part and includes: a large amount of brown residue which is consistent with lack of maintenance, burs pull out quite easily and the airline is loose and protrudes into the head cavity scrapping the impeller which also diminishes the performance and integrity of the turbine.Palisades dental determined that the failure of handpiece (b)(4) 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 instructs the user on cleaning instructions and to return the device to palisades dental for evaluation and service.See: [sus voluntary event report - mw5077317.Pdf].

Event Description

It was reported that on (b)(6) 2018 "that during a surgical procedure a 557 type burr came out of the handpiece inside of a (b)(6) female patient's mouth.A chest x-ray was performed.".

• Brand Name: IMPACT AIR 45
• Type of Device: DENTAL HANDPIECE
• 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: 7566855
• MDR Text Key: 109998666
• Report Number: 3003963943-2018-00001
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 403
• Device Lot Number: 5751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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
• Patient Age: 41 YR