|
Model Number 174317 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/29/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
According to the reporter, pre-operatively, when unboxing the device, it was realized that it was damaged.The device has scratch marks on it, along its length.There was no patient involvement.
|
|
Manufacturer Narrative
|
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the ratchet switch functioned correctly.The jaws securely locked on test media.It was reported that the device was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the atraumatic jaws are clamped and locked onto tissue structures by closing the handles.The endo clinch¿ ii 5 mm instrument has a ratchet mechanism that can be switched on or off, for user¿s preference.To activate the ratchet mechanism slide the ratchet button forward towards the jaw.To deactivate the ratchet mechanism, slide the ratchet button back towards the handle.Place the instrument on the tissue and close the handle to the most appropriate position for the tissue thickness.To release the tissue or structure from the jaws, when the ratchet mechanism is activated, simply pull the release lever on the handle.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Search Alerts/Recalls
|
|
|