Model Number LF1737 |
Device Problems
Detachment Of Device Component (1104); Component Missing (2306)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/19/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during a procedure, part of the insulation tip came off the jaw and fell apart.There was no patient injury.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
This event has been reassessed.The event is no longer considered a serious injury, and is now classified as a malfunction.Evaluation summary: one device sample was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the bottom jaw over mold was damaged and missing plastic.The disengaged plastic was not returned.The investigation found the bottom jaw over mold was damaged and missing plastic near the hinge of the device.The damage to the jaw's over mold likely occurred during the insertion or extraction of the device jaw from a trocar instrument.The investigation identified the root cause of the reported event to be user error.The instruction for use (ifu) states, carefully insert and withdraw the instrument through the cannula to avoid damage to the device and or injury to the patient.Close jaws using device handle before insertion/extraction in the trocar.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|