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Catalog Number 242018 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/22/2017 |
Event Type
malfunction
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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).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 additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by mitek express that the scope was cloudy.Issue found when device was returned to express care, no further information available.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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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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 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.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.Evaluation statement: the device was sent to the supplier for evaluation.Defects were identified and repaired.Supplier's finding summarized: the distal tip was damaged.Endoscope body was damaged/scratched.Cosmetic refurbishing of the scope was completed.Particles were found under the proximal cover of the glass.The internal components of the endoscope was leaky.The defects found during service could've caused the reported failure of a cloudy image.This complaint is confirmed.Possible root cause for the type of failures found during service could be from blunt force impact and/or improper handling of the scope during use, however a specific root cause could not be determined.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 these device families 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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