MAUDE Adverse Event Report: NAKANISHI, INC. NSK TI-MAX AK450L SU; HANDPIECE, AIR-POWERED, DENTAL

Model Number AK450L SU

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/26/2015

Event Type  malfunction  

Event Description

The following information is from nsk america corp to nakanishi inc (nsk) regarding a device manufactured by nsk.Event summary: on (b)(6) 2015 nsk america corp was made aware that a pt had been involved in an event where a handpiece head had detached while in use.The handpiece model is ak450l su sn (b)(4).Nsk america corp received the subject handpiece on 4/1/2015 from the dentist.Nsk america attempted to obtain additional information from the dentist office several times and has not received any response.Nakanishi is now investigating this event and will submit additional information including results obtained through the investigation as a follow-up report.

• Brand Name: NSK TI-MAX AK450L SU
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI, INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer (Section G): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer Contact: ken block ; 1201 richardson dr; ste 280; richardson, TX 75080 ; 9724809554
• MDR Report Key: 4766039
• MDR Text Key: 5797554
• Report Number: 9611253-2015-00076
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/07/2015

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: Other
• Device Model Number: AK450L SU
• Device Catalogue Number: P207001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other