Catalog Number 242400 |
Device Problems
Intermittent Loss of Power (4016); Unexpected Shutdown (4019)
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Patient Problems
Tissue Damage (2104); Not Applicable (3189)
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Event Date 09/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: the device was received at the service center, however the system was found to be irreparable.The camera head was found not be working, and a replacement camera head was sent.Given the information provided, we cannot discern a potential root cause for the reported failure.A review into the depuy synthes mitek complaints system revealed no other complaints for this serialized device with the product code that was released to distribution.At this point, 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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Event Description
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It was reported by the affiliate in (b)(6) that during laparoscopy, it was observed that the tck1 hd camera head device suddenly stopped working during the surgery.It was not reported if there was a delay in the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Awareness date reported on follow up 2 report as november 09, 2017 but should have been november 09, 2018.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.
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Manufacturer Narrative
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If additional information should become available, a supplemental medwatch will be submitted accordingly.Complaint review further determined that this complaint is a serious injury.Additional information: the date of event was reported as unknown in the initial report and has been updated as (b)(6) 2017.Updated investigation summary: the device was received at the service center, however the system was found to be irreparable.The camera head was found not be working, and a replacement camera head was sent.We cannot confirm the reported failure of intermittent operation since the device would not power on at the service center.Given the information provided, we cannot discern a potential root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi: (b)(4).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.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by dfa.Depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Investigation summary: the device was received at the service center, however the system was found to be irreparable.The camera head was found not be working, and a replacement camera head was sent.Given the information provided, we cannot discern a potential root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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.Udi: (b)(4).
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Search Alerts/Recalls
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