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

Model Number 401

Device Problems Device Maintenance Issue (1379); Inadequate Service (1564); Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

On 06/22/2017 mr.(b)(6) reported that the impact air 45 handpiece was last serviced in december, 2016 by davis handpiece service, (b)(4).According to an invoice that mr.(b)(6) had a copy of, the handpiece was cleaned and had a rebuild with a new turbine.When asked if the handpiece is available for palisades dental to evaluate, he indicated that it was placed in a safe at the dental office.On 06/22/2017: a review of impact air 45 fiberoptic handpiece batch record (b)(4), indicated that handpiece s/n (b)(4) was manufactured on 02/19/1999, and no abnormalities were found with the batch record or associated documentation.The review determined that the handpieces associated with batch record (b)(4) were released on 02/22/1999 (18+ years ago).On 06/26/2017: palisades dental, llc called (b)(6) dental care, (b)(6) and asked to speak with dr.(b)(6).The person who answered the phone explained that dr.(b)(6) was with a patient and not available.She further indicated that she believes that calls need to be directed to their corporate attorney, (b)(6).On 06/28/2017: palisades dental, llc called (b)(6) and he confirmed that all calls should be routed to him regarding the incident.He stated that he is the vice president of human resources and the compliance officer of (b)(6).It was explained that palisades dental has initiated an investigation and requested that the handpiece involved in the incident be sent to palisades dental for evaluation.Mr.(b)(6) said that the handpiece was sterilized after the procedure and then placed in a safe.Mr.(b)(6) confirmed that the patient went to the hospital and the parts that were swallowed were retrieved endoscopically.When asked about the head cap, mr.(b)(6) indicated that the patient did not swallow the head cap as it was recovered by either the dentist or da (dental assistant).When asked who was in possession of the parts that were swallowed by the patient and subsequently retrieved, mr.(b)(6) answered that he was not sure who is in possession of the parts that were swallowed.When asked if the fda had been notified of the event, he answered that it had not.On 06/30/2017: (b)(6) indicated that his office would send the handpiece and requested that it be returned to his attention after palisades dental, llc performs an examination of the handpiece.On 07/07/2017: handpiece serial (b)(4) was received at palisades dental, along with the head cap, but not the bur or the turbine assembly.A visual inspection determined that the head cap is a non-palisades dental part, additionally, thread wear on the handpiece is significant to the point that the head cap can be placed inside the cavity of the handpiece with no contact between the threads of each of these parts until the lower portion of the head cavity is reached.Palisades dental determined that the failure is not manufacturer related, rather it is repair/service related due to service and maintenance performed by facilities other than those specified in product labeling (i.E.Facilities other than palisades dental).It is palisades dental's determination that there is a device maintenance issue associated with the servicing of the device and maintenance does not comply to manufacturer's recommendations.Additionally, use of a non-palisades dental part (i.E.Head cap) and the significant thread wear in the head cavity of the handpiece are also contributing factors.Furthermore, handpiece serial (b)(4) was manufactured 18+ years ago and has never been sent to palisades dental for service or preventative maintenance as indicated in the care and use manual.

Event Description

It was reported that while a dentist was using an impact air 45 handpiece, serial (b)(4), on a patient the head cap came off of the handpiece.The patient was startled and swallowed the turbine and bur.The parts were removed endoscopically.As the parts were being removed, the bur scraped the patient's esophagus.When asked about the condition of the patient, it was reported that she is fine.

• Brand Name: IMPACT AIR 45
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): PALISADES DENTAL, LLC; 111 cedar lane; englewood 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: 6702572
• MDR Text Key: 79658910
• Report Number: 3003963943-2017-00002
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 401
• Device Lot Number: 3689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/1999
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR