SLIMLINE SIS
Report
- Report Number
- 2124215-2022-35538
- Event Type
- Injury
- Date Received
- September 13, 2022
- Date of Event
- March 16, 2022
- Report Date
- September 28, 2023
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- UDI-DI
- 07290109145556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED OBSERVATIONS WERE UNABLE TO BE CONFIRMED DUE TO THE DEVICE NOT BEING AVAILABLE FOR ANALYSIS. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU), CAREFUL HANDLING OF THE FIBER DURING SETUP IS IMPORTANT TO PREVENT FIBER DAMAGE. A DAMAGED FIBER MAY CAUSE ACCIDENTAL LASER EXPOSURE OR INJURY TO THE TREATMENT ROOM PERSONNEL OR PATIENT, AND/OR FIRE IN THE TREATMENT ROOM. THE IFU ALSO STATES THAT VERIFYING THE AIMING BEAM IS EXTREMELY IMPORTANT FOR THE SAFE OPERATION OF THE LASER EQUIPMENT. IT INSTRUCTS NOT TO USE THE LASER OR DELIVERY SYSTEM IF THE AIMING BEAM IS NOT VISIBLE. OPERATING THE LASER WITHOUT THE AIMING BEAM MAY RESULT IN LASER EXPOSURE TO NON TARGET TISSUE AND POSSIBLE INJURY. BASED ON ALL THE AVAILABLE INFORMATION AND THE REVIEW OF THE DEVICE IFU, THE MOST PROBABLE CAUSE OF THE REPORTED OBSERVATIONS IS A FAILURE TO FOLLOW INSTRUCTIONS.
D3 MANUFACTURER NAME AND ADDRESS CORRECTED. THE REPORTED OBSERVATIONS WERE UNABLE TO BE CONFIRMED DUE TO THE DEVICE NOT BEING AVAILABLE FOR ANALYSIS. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU), CAREFUL HANDLING OF THE FIBER DURING SETUP IS IMPORTANT TO PREVENT FIBER DAMAGE. A DAMAGED FIBER MAY CAUSE ACCIDENTAL LASER EXPOSURE OR INJURY TO THE TREATMENT ROOM PERSONNEL OR PATIENT, AND/OR FIRE IN THE TREATMENT ROOM. THE IFU ALSO STATES THAT VERIFYING THE AIMING BEAM IS EXTREMELY IMPORTANT FOR THE SAFE OPERATION OF THE LASER EQUIPMENT. IT INSTRUCTS NOT TO USE THE LASER OR DELIVERY SYSTEM IF THE AIMING BEAM IS NOT VISIBLE. OPERATING THE LASER WITHOUT THE AIMING BEAM MAY RESULT IN LASER EXPOSURE TO NON TARGET TISSUE AND POSSIBLE INJURY. BASED ON ALL THE AVAILABLE INFORMATION AND THE REVIEW OF THE DEVICE IFU, THE MOST PROBABLE CAUSE OF THE REPORTED OBSERVATIONS IS A FAILURE TO FOLLOW INSTRUCTIONS.
CORRECTION MADE TO D3 MANUFACTURE NAME, MANUFACTURE ADDRESS, MANUFACTURER CITY, MANUFACTURER ZIP/POSTAL CODE, MANUFACTURER COUNTRY, MANUFACTURER EMAIL, G1 MFR SITE FACILITY NAME, MFR SITE ADDRESS 1, MFR SITE CITY, MFR SITE STATE, MFR SITE ZIP, MFR SITE COUNTRY, MFR SITE PHONE. THE REPORTED OBSERVATIONS WERE UNABLE TO BE CONFIRMED DUE TO THE DEVICE NOT BEING AVAILABLE FOR ANALYSIS. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU), CAREFUL HANDLING OF THE FIBER DURING SETUP IS IMPORTANT TO PREVENT FIBER DAMAGE. A DAMAGED FIBER MAY CAUSE ACCIDENTAL LASER EXPOSURE OR INJURY TO THE TREATMENT ROOM PERSONNEL OR PATIENT, AND/OR FIRE IN THE TREATMENT ROOM. THE IFU ALSO STATES THAT VERIFYING THE AIMING BEAM IS EXTREMELY IMPORTANT FOR THE SAFE OPERATION OF THE LASER EQUIPMENT. IT INSTRUCTS NOT TO USE THE LASER OR DELIVERY SYSTEM IF THE AIMING BEAM IS NOT VISIBLE. OPERATING THE LASER WITHOUT THE AIMING BEAM MAY RESULT IN LASER EXPOSURE TO NON TARGET TISSUE AND POSSIBLE INJURY. BASED ON ALL THE AVAILABLE INFORMATION AND THE REVIEW OF THE DEVICE IFU, THE MOST PROBABLE CAUSE OF THE REPORTED OBSERVATIONS IS A FAILURE TO FOLLOW INSTRUCTIONS.
IT WAS REPORTED THAT DURING A TUL PROCEDURE, AFTER CRUSHING, EXTRACTION WAS PERFORMED IN A BASKET. THE FIBER WAS ROLLED AND BUNDLED AND SECURED TO THE DRAPE WITH CLOTH FORCEPS. ADDITIONAL CRUSHING WAS REQUIRED, SO THE LASING STARTED AGAIN. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE GUIDE LIGHT WAS NOT COMING OUT, BUT HE CONTINUED THE PROCEDURE INCREASING THE OUTPUT. WHEN THE PROCEDURE WAS CONTINUED, A DRAPE NEAR THE WHERE THE ROLLED FIBERS WERE IN CONTACT CAUGHT FIRE. THE DOCTORS AND NURSES PRESENT SPRAYED OFF SALINE SOLUTION. AT THIS POINT, THE PROCEDURE WAS CANCELLED. AFTER CONFIRMING THE PATIENT CONDITION, A 3 TO 5 CM BURN WAS CONFIRMED ON THE UPPER LEFT ANKLE. ACCORDING TO THE DERMATOLOGIST DIAGNOSIS, THE BURN WAS DEGREE II OR III.
IT WAS REPORTED THAT DURING A TUL PROCEDURE, AFTER CRUSHING, EXTRACTION WAS PERFORMED IN A BASKET. THE FIBER WAS ROLLED AND BUNDLED AND SECURED TO THE DRAPE WITH CLOTH FORCEPS. ADDITIONAL CRUSHING WAS REQUIRED, SO THE LASING STARTED AGAIN. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE GUIDE LIGHT WAS NOT COMING OUT, BUT HE CONTINUED THE PROCEDURE INCREASING THE OUTPUT. WHEN THE PROCEDURE WAS CONTINUED, A DRAPE NEAR THE WHERE THE ROLLED FIBERS WERE IN CONTACT CAUGHT FIRE. THE DOCTORS AND NURSES PRESENT SPRAYED OFF SALINE SOLUTION. AT THIS POINT, THE PROCEDURE WAS CANCELLED. AFTER CONFIRMING THE PATIENT CONDITION, A 3 TO 5 CM BURN WAS CONFIRMED ON THE UPPER LEFT ANKLE. ACCORDING TO THE DERMATOLOGIST DIAGNOSIS, THE BURN WAS DEGREE II OR III.
IT WAS REPORTED THAT DURING A TUL PROCEDURE, AFTER CRUSHING, EXTRACTION WAS PERFORMED IN A BASKET. THE FIBER WAS ROLLED AND BUNDLED AND SECURED TO THE DRAPE WITH CLOTH FORCEPS. ADDITIONAL CRUSHING WAS REQUIRED, SO THE LASING STARTED AGAIN. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE GUIDE LIGHT WAS NOT COMING OUT, BUT HE CONTINUED THE PROCEDURE INCREASING THE OUTPUT. WHEN THE PROCEDURE WAS CONTINUED, A DRAPE NEAR THE WHERE THE ROLLED FIBERS WERE IN CONTACT CAUGHT FIRE. THE DOCTORS AND NURSES PRESENT SPRAYED OFF SALINE SOLUTION. AT THIS POINT, THE PROCEDURE WAS CANCELLED. AFTER CONFIRMING THE PATIENT CONDITION, A 3 TO 5 CM BURN WAS CONFIRMED ON THE UPPER LEFT ANKLE. ACCORDING TO THE DERMATOLOGIST DIAGNOSIS, THE BURN WAS DEGREE II OR III.
IT WAS REPORTED THAT DURING A TUL PROCEDURE, AFTER CRUSHING, EXTRACTION WAS PERFORMED IN A BASKET. THE FIBER WAS ROLLED AND BUNDLED AND SECURED TO THE DRAPE WITH CLOTH FORCEPS. ADDITIONAL CRUSHING WAS REQUIRED, SO THE LASING STARTED AGAIN. AT THAT TIME, THE PHYSICIAN NOTICED THAT THE GUIDE LIGHT WAS NOT COMING OUT, BUT HE CONTINUED THE PROCEDURE INCREASING THE OUTPUT. WHEN THE PROCEDURE WAS CONTINUED, A DRAPE NEAR THE WHERE THE ROLLED FIBERS WERE IN CONTACT CAUGHT FIRE. THE DOCTORS AND NURSES PRESENT SPRAYED OFF SALINE SOLUTION. AT THIS POINT, THE PROCEDURE WAS CANCELLED. AFTER CONFIRMING THE PATIENT CONDITION, A 3 TO 5 CM BURN WAS CONFIRMED ON THE UPPER LEFT ANKLE. ACCORDING TO THE DERMATOLOGIST DIAGNOSIS, THE BURN WAS DEGREE II OR III.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1951336 | SLIMLINE SIS | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | 0644-017-01 | 0055760420 | 07290109145556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |