SLIMLINE
Report
- Report Number
- 2124215-2024-28430
- Event Type
- Injury
- Date Received
- May 10, 2024
- Date of Event
- September 1, 2016
- Report Date
- June 26, 2024
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K170121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
VILLA, L.; DIONI, P.; CANDELA, L.; VENTIMIGLIA, E.; DE ANGELIS, M.; CORSINI, C.; ROBESTI, D.; FANTIN, M.; D'ARMA, A.; PROIETTI, S.; ET AL. UNDERSTANDING THE ROLE OF URETERAL ACCESS SHEATH IN PREVENTING POST-OPERATIVE INFECTIOUS COMPLICATIONS IN STONE PATIENTS TREATED WITH URETEROSCOPY AND HO:YAG LASER LITHOTRIPSY: RESULTS FROM A TERTIARY CARE REFERRAL CENTER. J. CLIN. MED. 2023, 12, 1457. HTTPS:// DOI.ORG/10.3390/JCM12041457.
VILLA, L.; DIONI, P.; CANDELA, L.; VENTIMIGLIA, E.; DE ANGELIS, M.; CORSINI, C.; ROBESTI, D.; FANTIN, M.; D'ARMA, A.; PROIETTI, S.; ET AL. UNDERSTANDING THE ROLE OF URETERAL ACCESS SHEATH IN PREVENTING POST-OPERATIVE INFECTIOUS COMPLICATIONS IN STONE PATIENTS TREATED WITH URETEROSCOPY AND HO:YAG LASER LITHOTRIPSY: RESULTS FROM A TERTIARY CARE REFERRAL CENTER. J. CLIN. MED. 2023, 12, 1457. HTTPS:// DOI.ORG/10.3390/JCM12041457.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF CLINICAL MEDICINE THAT A STUDY WAS CONDUCTED IN ORDER TO INVESTIGATE WHETHER THE USE OF URETERAL ACCESS SHEATHS (UAS) WOULD AFFECT THE POSTOPERATIVE INFECTIOUS COMPLICATIONS RATES IN STONE PATIENTS WHO WERE TREATED WITH URETEROSCOPY (URS) PROCEDURES. DATA FROM 369 PATIENTS WHO WERE TREATED WITH URS FROM SEPTEMBER 2016 TO DECEMBER 2021 AT A SINGLE INSTITUTION WERE ANALYZED. ALL PROCEDURES WERE PERFORMED WITH THE PATIENTS UNDER GENERAL ANESTHESIA AND PLACED INTO A LITHOTOMY POSITION. A 100W HO:YAG CONSOLE WITH A 200 MICROMETER LASER FIBER AND A REGULAR ZEROTIP BASKET WERE USED TO PERFORM THE PROCEDURES. AFTER ALL OF THE PROCEDURES, A DOUBLE J (DJ) STENT WAS PLACED AND THE REMOVED IN AN OUTPATIENT SETTING WITHIN 7-10 DAYS POSTOPERATIVELY. OUT OF THE 369 PATIENTS, A TOTAL OF 451 PROCEDURES WERE PERFORMED. A TOTAL OF 52 PATIENTS REQUIRED MORE THAN ONE URS PROCEDURE: 38 PATIENTS UNDERWENT TWO PROCEDURES, 10 PATIENTS UNDERWENT THREE PROCEDURES, AND FOUR PATIENTS UNDERWENT FOUR OR MORE PROCEDURES. OUT OF THE 451 PROCEDURES, A TOTAL OF 52 PATIENTS EXPERIENCED FEVER, 10 PATIENTS HAD SEPSIS, AND SIX PATIENTS HAD SEPTIC SHOCK. OUT OF THE 52 CASES OF FEVER, 41 OCCURRED AT THE FIRST PROCEDURE, 5 OCCURRED AT THE SECOND PROCEDURE, AND 6 OCCURRED AT OR AFTER THE THIRD PROCEDURE. OUT OF THE 10 CASES OF UROSEPSIS, 8 OCCURRED AT THE FIRST PROCEDURE AND 2 OCCURRED AT THE THIRD PROCEDURE. OUT OF THE SIX CASES SEPTIC SHOCK, 5 OCCURRED AT THE 1ST PROCEDURE AND 1 OCCURRED AT THE THIRD PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF CLINICAL MEDICINE THAT A STUDY WAS CONDUCTED IN ORDER TO INVESTIGATE WHETHER THE USE OF URETERAL ACCESS SHEATHS (UAS) WOULD AFFECT THE POSTOPERATIVE INFECTIOUS COMPLICATIONS RATES IN STONE PATIENTS WHO WERE TREATED WITH URETEROSCOPY (URS) PROCEDURES. DATA FROM 369 PATIENTS WHO WERE TREATED WITH URS FROM SEPTEMBER 2016 TO DECEMBER 2021 AT A SINGLE INSTITUTION WERE ANALYZED. ALL PROCEDURES WERE PERFORMED WITH THE PATIENTS UNDER GENERAL ANESTHESIA AND PLACED INTO A LITHOTOMY POSITION. A 100W HO:YAG CONSOLE WITH A 200 MICROMETER LASER FIBER AND A REGULAR ZEROTIP BASKET WERE USED TO PERFORM THE PROCEDURES. AFTER ALL OF THE PROCEDURES, A DOUBLE J (DJ) STENT WAS PLACED AND THE REMOVED IN AN OUTPATIENT SETTING WITHIN 7-10 DAYS POSTOPERATIVELY. OUT OF THE 369 PATIENTS, A TOTAL OF 451 PROCEDURES WERE PERFORMED. A TOTAL OF 52 PATIENTS REQUIRED MORE THAN ONE URS PROCEDURE: 38 PATIENTS UNDERWENT TWO PROCEDURES, 10 PATIENTS UNDERWENT THREE PROCEDURES, AND FOUR PATIENTS UNDERWENT FOUR OR MORE PROCEDURES. OUT OF THE 451 PROCEDURES, A TOTAL OF 52 PATIENTS EXPERIENCED FEVER, 10 PATIENTS HAD SEPSIS, AND SIX PATIENTS HAD SEPTIC SHOCK. OUT OF THE 52 CASES OF FEVER, 41 OCCURRED AT THE FIRST PROCEDURE, 5 OCCURRED AT THE SECOND PROCEDURE, AND 6 OCCURRED AT OR AFTER THE THIRD PROCEDURE. OUT OF THE 10 CASES OF UROSEPSIS, 8 OCCURRED AT THE FIRST PROCEDURE AND 2 OCCURRED AT THE THIRD PROCEDURE. OUT OF THE SIX CASES SEPTIC SHOCK, 5 OCCURRED AT THE 1ST PROCEDURE AND 1 OCCURRED AT THE THIRD PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2498678 | SLIMLINE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-SLIMLINE_FIBERS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |