Catalog Number PFSR101209 |
Device Problems
Break (1069); Overheating of Device (1437)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/23/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference case (b)(4).
|
|
Event Description
|
It was reported that, during preventative maintenence, they performed a drill test on two anspach emax 2 plus hand piece - rohs and both started to smoke after 10 seconds and were too hot to touch.Also, surgeons have stated that the motor sound.It is suspected that internal lubricant has diminished and bearings not working correctly.No case involved; therefore, there was no patient involvement.
|
|
Manufacturer Narrative
|
H3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial sn (b)(4) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.A drill test was performed and a louder-than-expected noise was coming from the drill as well as smoke.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most probable cause of the reported problem is motor failure.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
|
|
Manufacturer Narrative
|
H3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial sn (21)(b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.A drill test was performed and a louder-than-expected noise was coming from the drill as well as smoke.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most probable cause of the reported problem is motor failure.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
|
|
Search Alerts/Recalls
|
|