DEPUY MITEK LLC US VAPR TRIPOLAR 90 SUCTION ELECT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 225028 |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Event Description
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It was reported by the affiliate in japan that during anarthroscopic surgery treating the shoulder on (b)(6) 2023, it was observed that when the surgeon connected the first tripolar device to the main body and stepped on the foot switch, the tripolar device didn't turn on and was not able to be used at all.The surgeon opened and connected the second tripolar device to the main body, but the second tripolar device didn't turn on either.The surgeon turned the main body off and on again, connected the second tripolar device again, and stepped on the yellow foot switch, but the situation continued for a while, with the power sometimes not turning on.As the second tripolar device was used, the connection became more stable, so the surgeon continued using it and managed to complete the surgery.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.Report 2 of 2 for (b)(4).
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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.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: d9: concomitant med products and therapy dates: unk - generator device, (b)(6) 2023 udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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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.H10 additional narrative: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, the investigation will be performed as appropriate.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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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