MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-05-05 for NSK SGA-E2S H265 manufactured by Nakanishi Inc..
[44476875]
Nakanishi inc. As manufacturer of the sgs-e2s dental handpiece is unable to conduct an investigation regarding the device in this event due to: the device in question was not returned to (b)(4), our importer or to nakanishi inc. Directly by the complainant. No serial number was provided by the complainant, so no evaluation of the device dhr could be conducted. Nakanishi conducted a review of the fda maude database and was unable to locate report 9611253-2014-00006 (this report). Nakanishi believes this report to have been submitted previously; however nakanishi is re-submitting this report to ensure that fda has a record of the report in the maude database. Device not returned by complainant.
Patient Sequence No: 1, Text Type: N, H10
[44476876]
On (b)(6) 2014, (b)(4) a nakanishi inc. Importer received a telephonic complaint of a handpiece allegedly causing a burn to a patient. Complainant only provided the model number to nsk america. The specific serial number of the device involved in this event is unknown. The (b)(4) employee contacted collected the following information from the doctor: handpiece heated up and caused a 2nd degree burn about 1cm area and healing of the wound left a slight scar. Dental procedure being performed was a wisdom tooth extraction. Patient was awake under local anesthetic. Handpiece was sent for service but not sent to (b)(4). Doctor stated reason for delay in reporting was that she was unable to find contact information for (b)(4). (b)(4) checked their internal service records and did not locate any records of them performing any repair activity for this doctor. Handpiece serial number was not known by the doctor and no further record searches could be performed to determine the date of sale of the handpiece to the doctor. (b)(4) sent a follow-up letter requesting additional information and return of the handpiece to dr. (b)(6) on (b)(6) 2014. As of september 3, 2014 (b)(4) has received no response from the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2014-00006 |
| MDR Report Key | 5633760 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-05-05 |
| Date of Report | 2018-07-10 |
| Date of Event | 2013-11-20 |
| Date Facility Aware | 2014-06-30 |
| Report Date | 2014-07-11 |
| Date Reported to FDA | 2014-07-11 |
| Date Reported to Mfgr | 2014-06-30 |
| Date Mfgr Received | 2018-06-09 |
| Date Added to Maude | 2016-05-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KENNETH BLOCK |
| Manufacturer Street | 800 E CAMPBELL RD. SUITE 202 |
| Manufacturer City | RICHARDSON TX 75081 |
| Manufacturer Country | US |
| Manufacturer Postal | 75081 |
| Manufacturer Phone | 9724809554 |
| Manufacturer G1 | NAKANISHI INC. |
| Manufacturer Street | 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, TOCHIGI-KEN 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 9611253-060818-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NSK SGA-E2S |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2016-05-05 |
| Model Number | SGA-E2S |
| Catalog Number | H265 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAKANISHI INC. |
| Manufacturer Address | 700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-05 |