Catalog Number CRWPRECISE |
Device Problem
Calibration Problem (2890)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg.Report number 3004608878-2019-00071.
|
|
Event Description
|
This is 1 of 2 reports.The sales representative reported on behalf of the customer that the loaners crw precise (crw precision arc system) and crw pbs (phantom base assembly) were used for surgery on (b)(6) 2019.When the coordinates were entered, it was noticed that the correct target was not achieved.After frequent checking of the settings and coordinates, the correct target was still not achieved.After surgery, the crw precise and crw pbs were put on zero (0).A deviation of almost 1 mm was noted.The conclusion was that the crw precise and crw pbs did not have the correct calibration conditions.Complementary information was received on 22mar2019 and 01apr2019 indicating that the they did not reach the exact point that they planned because of the uncalibrated crw precise and crw pbs.At the moment, the stimulation for the patient works using a low electric current for stimulation; in the future the current will increase so they hope the patient will not have side effects with a higher current because the sensor is not at the exact spot.Surgery took 30 minutes longer because of the incorrect calibration.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
The evaluation of the returned crw precision arc system found the device was out of specification and the pointer was found to be bent.Device history record reviewed showed no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.The reported complaint was confirmed.The findings were consistent with rough handling or improper use but, the underlying root cause for the reported event was not conclusively determined.
|
|
Search Alerts/Recalls
|