MOSES
Report
- Report Number
- 2124215-2023-55823
- Event Type
- Injury
- Date Received
- October 11, 2023
- Date of Event
- June 16, 2022
- Report Date
- October 30, 2023
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH USE OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. REFERENCE LITERATURE ARTICLE [PRIMARY IMPACT OF SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH ONE WORKING CHANNEL WHEN PERFORMING FLEXIBLE URETEROSCOPE WITH URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONE: IN BENCH AND RETROSPECTIVE CLINICAL STUDY] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES. TAKAAKI, I., SHUZO, H., SHINSUKE, O., FUKASHI, Y., MASAICHIRO, F., KOKI, T., MSATO, F., (2022). PRIMARY IMPACT OF SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH ONE WORKING CHANNEL WHEN PERFORMING FLEXIBLE URETEROSCOPE WITH URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONE: IN BENCH AND RETROSPECTIVE CLINICAL STUDY. INTERNATIONAL JOURNAL OF UROLOGY, 29, 1163-1169. DOI: 10.1111/IJU.14957. B.3 DATE OF EVENT: DATE OF THE ARTICLE WAS USED.
REFERENCE LITERATURE ARTICLE [PRIMARY IMPACT OF SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH ONE WORKING CHANNEL WHEN PERFORMING FLEXIBLE URETEROSCOPE WITH URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONE: IN BENCH AND RETROSPECTIVE CLINICAL STUDY] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES. TAKAAKI, I., SHUZO, H., SHINSUKE, O., FUKASHI, Y., MASAICHIRO, F., KOKI, T., MSATO, F., (2022). PRIMARY IMPACT OF SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH ONE WORKING CHANNEL WHEN PERFORMING FLEXIBLE URETEROSCOPE WITH URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONE: IN BENCH AND RETROSPECTIVE CLINICAL STUDY. INTERNATIONAL JOURNAL OF UROLOGY, 29, 1163-1169. DOI: 10.1111/IJU.14957. B.3 DATE OF EVENT: DATE OF THE ARTICLE WAS USED.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO COMPARE THE SIMULTANEOUS USE OF TWO DEVICES VERSUS A SINGLE DEVICE THROUGH A SINGLE WORKING CHANNEL IN FLEXIBLE URETEROSCOPY USING A URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONES. IN A CLINICAL STUDY, 156 PATIENTS WHO UNDERWENT FLEXIBLE URETEROSCOPY WITH A URETERAL ACCESS SHEATH FOR A URETERAL STONE IN MIDDLE AND UPPER URETER BETWEEN APRIL 2019 AND NOVEMBER 2021 WERE ASSESSED. ONE DEVICE WAS USED AT A TIME FOR 79 PATIENTS (S GROUP) AND TWO WERE SIMULTANEOUSLY USED FOR 77 (D-GROUP). SURGICAL OUTCOMES AND COMPLICATIONS WERE COMPARED. THERE WERE NO SIGNIFICANT DIFFERENCES OBSERVED IN TERMS OF INTRA AND POSTOPERATIVE COMPLICATIONS BETWEEN THE S GROUP AND THE D GROUP. INTRAOPERATIVE URETERAL INJURY GRADE, CLASSIFIED BY TRAXER AND THOMAS AND POSTOPERATIVE COMPLICATIONS, CLASSIFIED USING THE CLAVIEN DINDO GRADING SYSTEM, WERE NOTED. A 120 W HOLMIUM LASER WAS USED WITH A MOSES 200 D/F/L FIBER, ALONG WITH ADDITIONAL NON-BOSTON SCIENTIFIC DEVICES (I.E.,NITINOL BASKETS AND WORKING CHANNELS). ALL PROCEDURES WERE PERFORMED BY TWO ENDOUROLOGICAL EXPERTS AT THE AUTHOR S INSTITUTION. 34.1 PERCENT OF PATIENTS FROM S GROUP EXPERIENCED EDEMA VERSUS 41.5 PERCENT FROM D GROUP. 29.1 PERCENT FROM S GROUP EXPERIENCED EDEMA PLUS POLYP VERSUS 28.5 PERCENT FROM D GROUP. DURING OPERATION, 97.4 PERCENT OF S GROUP EXPERIENCED URETERAL INJURY (NO URETERAL LESIONS OR ONLY MUCOSAL PETECHIAE) COMPARED TO 94.8 PERCENT FROM D GROUP. 2.5 PERCENT FROM S GROUP EXPERIENCED MUCOSAL EROSION OR A MUCOSAL FLAP WITHOUT SMOOTH MUSCLE INJURY COMPARED TO 5.1 PERCENT FROM D GROUP. FIVE PERCENT FROM S GROUP HAD GRADE I CLAVIEN-DINDO GRADE POST-OPERATIVE COMPLICATIONS (ANY DEVIATION FROM THE NORMAL POSTOPERATIVE COURSE WHERE NO PHARMACOLOGICAL OR SURGICAL TREATMENT, ENDOSCOPIC OR RADIOLOGICAL INTERVENTIONS WERE REQUIRED) COMPARED TO 2.5 PERCENT FROM D GROUP. 1.2 PERCENT FROM S GROUP HAD GRADE II CLAVIEN DINDO POST-OPERATIVE COMPLICATIONS (NORMAL COURSE ALTERED- PHARMACOLOGICAL MANAGEMENT OTHER THAN IN GRADE 1. BLOOD TRANSFUSIONS AND TOTAL PARENTERAL NUTRITION ARE ALSO INCLUDED) COMPARED TO 1.2 FROM D GROUP. BASED ON DATA AND ANALYSIS COLLECTED THROUGHOUT THE EXPERIMENT, THE AUTHOR CONCLUDES THAT SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH A SINGLE WORKING CHANNEL IN FLEXIBLE URETEROSCOPY (FURS) IS SAFE AND MAY BE USEFUL FOR OMITTING THE TIME TO EXCHANGE THE LASER FIBER AND THE NITINOL BASKET. THIS METHOD MIGHT BE A POSSIBLE TECHNIQUE THAT UROLOGISTS MAY USE AS IT CONTRIBUTES TO SHORTENING THE OPERATION TIME IN FURS FOR URETERAL STONE MANAGEMENT. REFERENCE LITERATURE ARTICLE [PRIMARY IMPACT OF SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH ONE WORKING CHANNEL WHEN PERFORMING FLEXIBLE URETEROSCOPE WITH URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONE: IN BENCH AND RETROSPECTIVE CLINICAL STUDY] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED TO COMPARE THE SIMULTANEOUS USE OF TWO DEVICES VERSUS A SINGLE DEVICE THROUGH A SINGLE WORKING CHANNEL IN FLEXIBLE URETEROSCOPY USING A URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONES. IN A CLINICAL STUDY, 156 PATIENTS WHO UNDERWENT FLEXIBLE URETEROSCOPY WITH A URETERAL ACCESS SHEATH FOR A URETERAL STONE IN MIDDLE AND UPPER URETER BETWEEN APRIL 2019 AND NOVEMBER 2021 WERE ASSESSED. ONE DEVICE WAS USED AT A TIME FOR 79 PATIENTS (S GROUP) AND TWO WERE SIMULTANEOUSLY USED FOR 77 (D-GROUP). SURGICAL OUTCOMES AND COMPLICATIONS WERE COMPARED. THERE WERE NO SIGNIFICANT DIFFERENCES OBSERVED IN TERMS OF INTRA AND POSTOPERATIVE COMPLICATIONS BETWEEN THE S GROUP AND THE D GROUP. INTRAOPERATIVE URETERAL INJURY GRADE, CLASSIFIED BY TRAXER AND THOMAS AND POSTOPERATIVE COMPLICATIONS, CLASSIFIED USING THE CLAVIEN DINDO GRADING SYSTEM, WERE NOTED. A 120 W HOLMIUM LASER WAS USED WITH A MOSES 200 D/F/L FIBER, ALONG WITH ADDITIONAL NON-BOSTON SCIENTIFIC DEVICES (I.E.,NITINOL BASKETS AND WORKING CHANNELS). ALL PROCEDURES WERE PERFORMED BY TWO ENDOUROLOGICAL EXPERTS AT THE AUTHOR S INSTITUTION. 34.1 PERCENT OF PATIENTS FROM S GROUP EXPERIENCED EDEMA VERSUS 41.5 PERCENT FROM D GROUP. 29.1 PERCENT FROM S GROUP EXPERIENCED EDEMA PLUS POLYP VERSUS 28.5 PERCENT FROM D GROUP. DURING OPERATION, 97.4 PERCENT OF S GROUP EXPERIENCED URETERAL INJURY (NO URETERAL LESIONS OR ONLY MUCOSAL PETECHIAE) COMPARED TO 94.8 PERCENT FROM D GROUP. 2.5 PERCENT FROM S GROUP EXPERIENCED MUCOSAL EROSION OR A MUCOSAL FLAP WITHOUT SMOOTH MUSCLE INJURY COMPARED TO 5.1 PERCENT FROM D GROUP. FIVE PERCENT FROM S GROUP HAD GRADE I CLAVIEN-DINDO GRADE POST-OPERATIVE COMPLICATIONS (ANY DEVIATION FROM THE NORMAL POSTOPERATIVE COURSE WHERE NO PHARMACOLOGICAL OR SURGICAL TREATMENT, ENDOSCOPIC OR RADIOLOGICAL INTERVENTIONS WERE REQUIRED) COMPARED TO 2.5 PERCENT FROM D GROUP. 1.2 PERCENT FROM S GROUP HAD GRADE II CLAVIEN DINDO POST-OPERATIVE COMPLICATIONS (NORMAL COURSE ALTERED- PHARMACOLOGICAL MANAGEMENT OTHER THAN IN GRADE 1. BLOOD TRANSFUSIONS AND TOTAL PARENTERAL NUTRITION ARE ALSO INCLUDED) COMPARED TO 1.2 FROM D GROUP. BASED ON DATA AND ANALYSIS COLLECTED THROUGHOUT THE EXPERIMENT, THE AUTHOR CONCLUDES THAT SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH A SINGLE WORKING CHANNEL IN FLEXIBLE URETEROSCOPY (FURS) IS SAFE AND MAY BE USEFUL FOR OMITTING THE TIME TO EXCHANGE THE LASER FIBER AND THE NITINOL BASKET. THIS METHOD MIGHT BE A POSSIBLE TECHNIQUE THAT UROLOGISTS MAY USE AS IT CONTRIBUTES TO SHORTENING THE OPERATION TIME IN FURS FOR URETERAL STONE MANAGEMENT. REFERENCE LITERATURE ARTICLE [PRIMARY IMPACT OF SIMULTANEOUS USE OF DOUBLE DEVICES THROUGH ONE WORKING CHANNEL WHEN PERFORMING FLEXIBLE URETEROSCOPE WITH URETERAL ACCESS SHEATH FOR SINGLE URETERAL STONE: IN BENCH AND RETROSPECTIVE CLINICAL STUDY] INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2164198 | MOSES | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-MOSES_FIBERS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other | 120 W HOLMIUM LASER.| 120 W HOLMIUM LASER. |