Model Number 8360-10 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/16/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If additional information or investigation results become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported to aesculap inc.That there was an issue with prestige atra grasper dbl-act 5mm (part #8360-10).According to the complainant, during an unspecified procedure, the grasper did not hold the patient tissue.Further details were not provided.The malfunction is filed under aic reference (b)(4).
|
|
Manufacturer Narrative
|
Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device revealed that the jaws were not meeting properly when closed.Additionally, the device appeared to have been repaired by a third party.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the reported event was able to confirm closing difficulty.Reportedly, the jaws failed to meet properly when closed.
|
|
Search Alerts/Recalls
|