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Catalog Number 242018 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.Udi: (b)(4).The device was received and evaluated at the service center.The customer requested a repair, defects were found with the device during evaluation, therefore we can confirm this complaint.It was found that the endoscope has been stained.The endoscope was replaced and the device was tested and found to be working according to specifications.User mishandling during storage or cleaning is the most likely root cause for the staining of the endoscope.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), 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.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified.
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Event Description
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It was reported by the affiliate in (b)(6) that the hd epscp needes to be repaired for an unspecified malfunction.During repair, an evaluation was performed and it was determined that the endoscope device had been stained.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device was available for use to complete the surgery.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the device was received and evaluated at the service center.The customer requested a repair, defects were found with the device during evaluation, therefore we can confirm this complaint.It was found that the endoscope has been stained.The endoscope was replaced and the device was tested and found to be working according to specifications.User mishandling during storage or cleaning is the most likely root cause for the staining of the endoscope.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), 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.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified.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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Search Alerts/Recalls
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