Model Number 2001T-15 |
Device Problem
Break (1069)
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Patient Problem
Sedation (2368)
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Event Date 01/25/2018 |
Event Type
malfunction
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Event Description
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It was reported the blade broke off inside a patient's brain.
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Manufacturer Narrative
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Information in the referenced 'blocks' below was added/corrected within this mdr follow-up report: 'no' is being selected to clarify this single-use device was not reprocessed.(lot# and expiration date) - during the follow-up, the customer provided the importer with the lot# of the reported defective device; therefore, the identification of the device's expiration was able to be determined.The lot# (171309ac) and expiration date (01aug2022) of the reported device has been added to this follow-up mdr report.The follow-up# has been updated to reflect the sequence of this follow-up mdr report being submitted.The 'date of this report' is being updated to reflect today's submission of this follow-up mdr report.Due to the reporting of the lot# from the customer, the 'approximate age of the device' (6 months) was able to be determined.Therefore, the approximate age of the device is being added to this follow-up mdr report.The date 'report sent to fda' reflects today's date for the submission of this mdr follow-up report to the fda.The date 'report sent to manufacturer' reflects today's date for the submission of this mdr follow-up report to the manufacturer.The manufacturer's email was inadvertently omitted and is being added to this mdr follow-up report.This mdr follow-up report includes the mfr report#, therefore, this section is being completed where applicable.This mdr follow-up report includes the mfr report#, therefore, this section is being completed where applicable.Manufacturer's narrative: the manufacturer, niraj industries pvt.Ltd.Was notified of the complaint reported as highlighted within this mdr report.Due to the customer failing to provide the manufacturer with the actual device, the manufacturer could not conduct an appropriate investigation to examine the reported device.However, the manufacturer took remedial action to examine retain sample of the reported complaint batch located at their facility.As all the device characteristics (i.E.Hardness, stiffness, handle fitting, sharpness) that can induce blade breakage were observed to be within specification.The exact cause of the complaint cannot be established in absence of the defective sample.The most probable cause of blade breakage could be excessive application of lateral force during procedure or any other abnormal use conditions.As a cautionary measure, all the concerned persons have been educated to take care of all possibilities of blade breakage during process & inspection.Based off the manufacturer's investigation results provided above, we are moving to close this complaint file and consider this mdr closed.
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Event Description
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The blade broke off right at the base in back of the patient.An xray was taken and showed that the blade was in fact in the patient and they went through 2 hours to remove after 3 hour surgery.When they were trying to remove the blade, it keeps sliding forward which pierced through the spinal cord but there was no permanent damage.
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Manufacturer Narrative
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(b)(6) 2020: information below added to the original submission: b5: clarificaiton was added during the investigation by the customer that the blade broke in the patient's back, not the patient's brain as first reported.The issue statement was updated to reflect this change.D5: "health professional" was added to the original submission.G7: follow up report was indicated.H2: supplemental report requested by the fda as original record was missing from the record.
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Event Description
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It was reported the base of the blade broke off inside a patient's back.An xray was taken and showed part of the blade remained in the patient.Patient underwent additional time in surgery to remove the blade fragment.When trying to remove the blade fragment, the blade was advanced and pierced the spinal cord, but no permanant damage was reported.
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Manufacturer Narrative
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002 (b)(6)2020: information below added to the follow-up submission g7: follow up number "002" added h6: added conclusion code h10: narrative updated; closure indicated.Additional narrative: due to the customer failing to provide the manufacturer with the actual device, we could not conduct an appropriate investigation to examine the reported device.However, we took remedial action to examine retain sample of the reported complaint batch located at their facility.As all the device characteristics (i.E.Hardness, stiffness, handle fitting, sharpness) that can induce blade breakage were observed to be within specification.The exact cause of the complaint cannot be established in absence of the defective sample.The most probable cause of blade breakage could be excessive application of lateral force during procedure or any other abnormal use conditions.As a cautionary measure, all the concerned persons have been educated to take care of all possibilities of blade breakage during process & inspection.Based on the results of our investigation, we have closed this complaint file and consider this mdr closed.001 (b)(6) 2020: information below added to the original submission: b5: clarificaiton was added during the investigation by the customer that the blade broke in the patient's back, not the patient's brain as first reported.The issue statement was updated to reflect this change.D5: "health professional" was added to the original submission.G7: follow up report was indicated.H2: supplemental report requested by the fda as original record was missing from the record.
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Event Description
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It was reported the base of the blade broke off inside a patient's back.An xray was taken and showed part of the blade remained in the patient.Patient underwent additional time in surgery to remove the blade fragment.When trying to remove the blade fragment, the blade was advanced and pierced the spinal cord, but no permanant damage was reported.
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Search Alerts/Recalls
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