|
Model Number 288233 |
Device Problem
Difficult to Advance (2920)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/30/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
|
|
Event Description
|
It was reported by the customer that the auto capture of the expressew iii autocapture + suture passer device was not seated.There was no procedure nor patient involvement reported.No additional information was provided.
|
|
Manufacturer Narrative
|
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed wear marks on the device.It was found a label with legend ¿auto capture no seated¿.The laser etch on the shaft of the device were slightly faded.To test its functionality, it was tested on a sample rubber strip; as a result, the upper jaw was slightly loose when the jaws are closed; therefore, it showed that the jaws did not close normally and did not maintain the necessary grip pressure when its closed.The needle load and deploy procedure without anomalies.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.According with the visual inspection and the functional test result, this complaint can be confirmed.The possible root cause for the condition of the jaw can be attributed when clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess load on the jaws causing it to eventually damage the jaw.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function.Visually inspect the instrument and check for damage and wear.Also, jaws and teeth should align properly.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
|
|
Search Alerts/Recalls
|
|
|