GLASSVAN
Report
- Report Number
- 1058382-2018-00002
- Event Type
- Injury
- Date Received
- January 26, 2018
- Date of Event
- January 25, 2018
- Report Date
- January 26, 2018
- Manufacturer
- M/S NIRAJ INDUSTRIES PVT. LTD.
- Product Code
- GES
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- VA, US
- Reporter Occupation
- 501
Narratives
CORRECTED DATA AND CLOSURE: INFORMATION IN THE REFERENCED 'BLOCKS' BELOW WAS ADDED/CORRECTED WITHIN THIS MDR FOLLOW-UP REPORT: 1. D8 - 'NO' IS BEING SELECTED TO CLARIFY THIS SINGLE-USE DEVICE WAS NOT REPROCESSED. 2. D4 - (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. 3. F7 - THE FOLLOW-UP# HAS BEEN UPDATED TO REFLECT THE SEQUENCE OF THIS FOLLOW-UP MDR REPORT BEING SUBMITTED. 4. F8 - THE 'DATE OF THIS REPORT' IS BEING UPDATED TO REFLECT TODAY'S SUBMISSION OF THIS FOLLOW-UP MDR REPORT. 5. F9 - 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. 6. F11 - THE DATE 'REPORT SENT TO FDA' REFLECTS TODAY'S DATE FOR THE SUBMISSION OF THIS MDR FOLLOW-UP REPORT TO THE FDA. 7. F13 - THE DATE 'REPORT SENT TO MANUFACTURER' REFLECTS TODAY'S DATE FOR THE SUBMISSION OF THIS MDR FOLLOW-UP REPORT TO THE MANUFACTURER. 8. F14 - THE MANUFACTURER'S EMAIL WAS INADVERTENTLY OMITTED AND IS BEING ADDED TO THIS MDR FOLLOW-UP REPORT. 9. BLOCK G - THIS MDR FOLLOW-UP REPORT INCLUDES THE MFR REPORT#, THEREFORE, THIS SECTION IS BEING COMPLETED WHERE APPLICABLE. 10. BLOCK H - 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.
CORRECTED DATA: THE FOLLOWING BLOCKS WERE CORRECTED WITHIN THIS FOLLOW-UP MDR REPORT: 1. BLOCK B1 - BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER, 'ADVERSE EVENT' HAS BEEN SELECTED TO IDENTIFY THE EVENT REPORTED. 2. BLOCK D5 - THE DESCRIPTION OF THE EVENT/PROBLEM HAS BEEN UPDATED AS CLARIFICATION OF THE EVENT WAS PROVIDED FROM THE INITIAL REPORTER. 3. BLOCK E1 - SPELLING CORRECTION; BLANCHRDSTOWN TO BLANCHARDSTOWN. 4. BLOCK E3 - THE INITIAL REPORTER'S OCCUPATION IS QUALITY SPECIALIST, NOT DISTRIBUTOR. 5. BLOCK F7 - THE TYPE OF REPORT HAS BEEN UPDATED FROM 'INITIAL' TO 'FOLLOW-UP' DUE TO ADDITIONAL AND/OR CORRECTED INFORMATION BEING INCORPORATED INTO THIS MDR REPORT. 6. BLOCK F8 - THE DATE OF THIS REPORT IS BEING UPDATED AS THIS FOLLOW-UP REPORT IS BEING SUBMITTED TODAY. 7. BLOCK F10 - BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER, A PATIENT CODE HAS BEEN ADDED TO THIS MDR REPORT, THEREFORE, CORRELATING WITH THE ADVERSE EVENT IDENTIFIED. 8. BLOCK F11 - THE DATE OF THIS REPORT IS BEING UPDATED AS THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO THE FDA TODAY. 9. BLOCK F13 - THE DATE OF THIS REPORT IS BEING UPDATED AS THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO THE MANUFACTURER TODAY. 10. BLOCK F14 - THE CITY/PROVIDENCE OF THE MANUFACTURER HAS BEEN UPDATED AS REFLECTED ON THE FDA'S ESTABLISHMENT REGISTRATION LISTING WEBSITE (AS REFLECTED IN BLOCK D3). 11. BLOCK H10 - AS LISTED, CORRECTED AND ADDITIONAL DATA ADDED, THEREFORE, THIS FOLLOW-UP REPORT WAS CREATED.
THE FOLLOWING BLOCKS WERE CORRECTED WITHIN THIS FOLLOW-UP MDR REPORT: 1. B3 - THE CORRECT DATE FOR 'DATE OF EVENT' IS 25JAN2018 AS CLARIFIED BY THE CUSTOMER. 2. D3 - UPDATE DATE OF THE MANUFACTURER'S FAX# CONFIRMED BY THE MANUFACTUERER; CHANGED FROM 253-239-3609 TO 91-129-4061164. 3. D10 - THE DEVICE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, AN UPDATE WAS MADE TO SELECT 'NO' FOR THIS QUESTION. 4. E1 - THE INITIAL REPORTER HAS BEEN CORRECTED FROM (B)(6). (B)(6) IS THE CORRECT INITIAL REPORT AS IDENTIFIED IN EMAIL NOTIFICATIONS SENT TO THE IMPORTER; THEREFORE, THIS INITIAL REPORTER'S CONTACT INFORMATION IS BEING INCLUDED IN THIS FOLLOW-UP MDR REPORT. 5. E3 - BASED OFF THE CLARIFICATION OF IDENTIFYING THE INITIAL REPORTER IN BLOCK E1, THE OCCUPATION OF THE INITIAL REPORT HAS BEEN UPDATED. 6. F7 - THE FOLLOW-UP# HAS BEEN UPDATED TO REFLECT THE SEQUENCE OF THIS FOLLOW-UP MDR REPORT BEING SUBMITTED. 7. F11 - THE DATE REPORT SENT TO FDA REFLECTS TODAY'S DATE FOR THE SUBMISSION DATE OF THIS UPDATED FOLLOW-UP MDR REPORT TO THE FDA. 8. F13 - THE DATE REPORT SENT TO MANUFACTURER REFLECTS TODAY'S DATE FOR THE SUBMISSION DATE OF THIS UPDATED FOLLOW-UP MDR REPORT TO THE MANUFACTURER. 9. F14 - UPDATE DATE OF THE MANUFACTURER'S FAX# CONFIRMED BY THE MANUFACTURER; CHANGED FROM 253-239-3609 TO 91-129-4061164.
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.
THE BLADE BROKE OFF RIGHT AT THE BASE IN THE 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.
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.
THE BLADE BROKE OFF INSIDE A PATIENT'S BRAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67057 | GLASSVAN | BLADE | GES | M/S NIRAJ INDUSTRIES PVT. LTD. | 2001T-15 | 171309AC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |