MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-31 for SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE 4203000000 manufactured by Stryker Instruments-kalamazoo.
[5577707]
It was reported by the customer that the handpiece started smoking during a surgical procedure and the room was filled with white smoke. There was a delay of 45 minutes due to this event. The procedure was completed successfully using back-up equipment. No medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[13096238]
The device has not been received at the manufacturer for testing.? An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[20153022]
It was reported by the customer that the handpiece started smoking during a sugical procedure and the room was filled with white smoke. There was a delay of 45 minutes due to this event. The procedure was completed successfully using back-up equipment. No medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[20529212]
The reported event, device made a loud noise and started smoking, was not duplicated and no failures were confirmed as the device was not returned for evaluation. Device was not returned to the manufacturer facility for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-01180 |
| MDR Report Key | 4643174 |
| Report Source | 06 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-04 |
| Date of Event | 2015-03-04 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2005-12-16 |
| Date Added to Maude | 2015-03-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-03-31 |
| Catalog Number | 4203000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-31 |