Model Number 242401 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
Not Applicable (3189)
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Event Date 09/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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.Udi: (b)(4).
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Event Description
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It was reported by the sales rep via email that during a shoulder scope the camera head ac - c-mount had a short in the cord.Another device was used to complete the procedure.No patient consequences.2 minutes delay reported.The device is available to be returned for evaluation.
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Manufacturer Narrative
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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 device was received and evaluated at the service center.The reported complaint that the unit had a short in the cord was unable to be confirmed.However, it was found that the camera head was physically damaged.The repair of the device was however declined and was placed into long term hold.The physical damage to the camera head is most likely a result of user mishandling, or a probable fall.However, since the reported condition is not confirmed, the root cause for the reported failure cannot be determined.A manufacturing record evaluation was performed for the finished device [serial number : (b)(6)], and no non-conformances were identified.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.
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Manufacturer Narrative
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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: a manufacturing record evaluation was performed for the finished device [1802ce0337] number, and no non-conformances were identified.D10, 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.
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Search Alerts/Recalls
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