MEDOS INTERNATIONAL SÃ RL UNK - ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
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Catalog Number UNK - ELECTRODE |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d1, d4, g1, g4 (510k), h4: this report is for an unknown electrode device.Part and lot number are unknown.Without the specific part number; the expiration date, udi number, 510-k number, manufacturing site name, and device manufacture date are unknown.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.
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Event Description
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This is report 2 of 2 for (b)(4).It was reported by a healthcare professional in australia that during a rotator cuff repair surgical procedure on an unknown date in (b)(4) 2024, it was observed that the an unknown electrode device and a vapr vue generator device stopped working while in use together.According to the report, after troubleshooting the problem, an electronic burnt smell was emitted from the generator.It was reported that the electrode was swapped but with same outcome.It was reported that the generator was replaced to complete the surgery successfully with a delay of four minutes.There were no adverse patient consequences reported.No additional information was provided.
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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 complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot/serial number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot/serial number becomes available, the mre review will be performed.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.
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