DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC
|
Back to Search Results |
|
Model Number 284590 |
Device Problem
Improper Flow or Infusion (2954)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/16/2020 |
Event Type
malfunction
|
Manufacturer 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 sales rep that during a knee arthroscopy procedure on (b)(6) 2020, it was observed that the pump device had a weak flow.They were able to complete the procedure with the same device without delay.There were no adverse patient consequences 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.H10 additional narrative: 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 pursuantpor tme 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 device was received and evaluated at the service center.The reported complaint that the device had weak flow was confirmed.It was found that the device had clear signs of being dropped and the housing was damaged.Also an internal worn gear was found, which was identified as the root cause of the low flow from the pump.The damaged components of the device were replaced and the device was tested and found to be working according to specifications.User mishandling during storage or transport is the most probable root cause of the possible drop and physical damage to the device.The worn gear is most probably a result of prolonged usage of the device over time.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6) 2018 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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
|
|
|