FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER
Report
- Report Number
- 3005099803-2021-00751
- Event Type
- Malfunction
- Date Received
- February 25, 2021
- Date of Event
- January 28, 2021
- Report Date
- April 12, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GEX
- UDI-DI
- 08714729963820
- PMA / PMN Number
- K100078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
BLOCK H6: MEDICAL DEVICE PROBLEM CODE A1005 CAPTURES THE REPORTABLE EVENT OF FIBER CONNECTOR OVERHEATS. MEDICAL DEVICE PROBLEM CODE A0406 CAPTURES THE REPORTABLE EVENT TIP/FACE DEFORMATION. MEDICAL DEVICE PROBLEM CODE A040610 CAPTURES THE REPORTABLE EVENT OF SMA BOOT MELTED. BLOCK H10: THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. BLOCK H11: CORRECTION TO FIELD H6: MEDICAL DEVICE PROBLEM CODE A040610 CAPTURES THE REPORTABLE EVENT OF SMA BOOT MELTED.
BLOCK H6: MEDICAL DEVICE PROBLEM CODE A1005 CAPTURES THE REPORTABLE EVENT OF FIBER CONNECTOR OVERHEATS. MEDICAL DEVICE PROBLEM CODE A0406 CAPTURES THE REPORTABLE EVENT TIP/FACE DEFORMATION. MEDICAL DEVICE PROBLEM CODE A040610 CAPTURES THE REPORTABLE EVENT OF SMA BOOT MELTED. BLOCK H10: INVESTIGATION RESULTS THE RETURNED FLEXIVA ID 1000 LASER FIBER WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT IT WAS RETURNED IN ONE PIECE. THE FIBER MEASURED 278 CM FROM THE END OF THE CONNECTOR TO THE END OF THE EXPOSED GLASS TIP. THE EXPOSED GLASS TIP MEASURED WAS DEGRADED DOWN TO THE FIBER JACKET. EXAMINATION UNDER MAGNIFICATION CONFIRMED THE PATTERN OF THE TIP IS CONSISTENT WITH NORMAL DEGRADATION. ADDITIONALLY, THE CONNECTOR HOUSING WAS DEFORMED AND THE SMA BOOT WAS DETACHED, LIKELY DUE TO OVERHEATING. LIGHT FROM THE SMA CONNECTOR WAS BRIGHT AND ROUND, INDICATING NO FRACTURE WITHIN THE FIBER CONNECTOR. NO OTHER ISSUES WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. THE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SMA CONNECTOR WAS DEFORMED AND THE SMA BOOT DETACHED, LIKELY FROM OVERHEATING, AND THE FIBER TIP HAD A NORMAL DEGRADATION. LIGHT FROM THE SMA CONNECTOR WAS BRIGHT AND ROUND, INDICATING NO FRACTURES WITHIN THE CONNECTOR. PRODUCT ANALYSIS IDENTIFIED EXPOSED GLASS TIP WAS DEGRADED DUE TO HEAVY USAGE AND THE SMA CONNECTOR WAS DEFORMED AND SMA BOOT DETACHED DUE TO OVERHEATING. IT IS LIKELY THAT PROCEDURAL CONDITIONS AND OVERHEATING AT THE FIBER CONSOLE PORT CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 2, 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 WATT LASER CONSOLE. DURING THE PROCEDURE, WHEN CONNECTING THE LASER FIBER, THE PHYSICIAN NOTICED THAT IT WAS WARM TO TOUCH. THE PHYSICIAN RECONNECTED THE LASER FIBER AND NOTED THAT THE CONNECTOR WAS BURNED AND RESHAPED AT THE TIP. REPORTEDLY, THERE WAS NO BURN INJURY TO THE PATIENT OR TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 WATT LASER CONSOLE. DURING THE PROCEDURE, WHEN CONNECTING THE LASER FIBER, THE PHYSICIAN NOTICED THAT IT WAS WARM TO TOUCH. THE PHYSICIAN RECONNECTED THE LASER FIBER AND NOTED THAT THE CONNECTOR WAS BURNED AND RESHAPED AT THE TIP. REPORTEDLY, THERE WAS NO BURN INJURY TO THE PATIENT OR TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
(B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 2, 2021 THAT A FLEXIVA ID 1000 LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS A MOSES P120 WATT LASER CONSOLE. DURING THE PROCEDURE, WHEN CONNECTING THE LASER FIBER, THE PHYSICIAN NOTICED THAT IT WAS WARM TO TOUCH. THE PHYSICIAN RECONNECTED THE LASER FIBER AND NOTED THAT THE CONNECTOR WAS BURNED AND RESHAPED AT THE TIP. REPORTEDLY, THERE WAS NO BURN INJURY TO THE PATIENT OR TO THE USER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA ID 1000 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276919 | FLEXIVA (TM) ID HIGH POWER SINGLE-USE LASER FIBER | POWERED LASER SURGICAL INSTRUMENT | GEX | BOSTON SCIENTIFIC CORPORATION | M006R8403941 | 0000009348 | 08714729963820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |