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Model Number 2001T-15
Device Problem Break (1069)
Patient Problem Sedation (2368)
Event Date 01/25/2018
Event Type  malfunction  
Event Description
It was reported the blade broke off inside a patient's brain.
Manufacturer Narrative
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.
Event Description
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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Type of DeviceBLADE
Manufacturer (Section D)
plot 177, sector 25
ballabgarth, faridabad haryana 12100 4
IN 121004
MDR Report Key7284037
MDR Text Key194149469
Report Number8040409-2018-00002
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Inspection
Type of Report Initial,Followup,Followup,Followup
Report Date 02/20/2016,01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2001T-15
Device Lot Number171309AC
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/20/2016
Distributor Facility Aware Date01/26/2018
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer02/20/2018
Date Manufacturer Received01/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/20/2018 Patient Sequence Number: 1