SLIMLINE
Report
- Report Number
- 2124215-2024-83887
- Event Type
- Injury
- Date Received
- January 14, 2025
- Date of Event
- July 29, 2013
- Report Date
- February 20, 2025
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K170121
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOMS ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. RELATED REPORT THIS REPORT IS RELATED TO 2124215-2025-01126 FOR THE VERSA PULSE CONSOLE REPORT. BLOCK B3 THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2013, WAS CHOSEN AS THE BEST ESTIMATE BASED ON YEAR THE ARTICLE WAS ACCEPTED. BLOCK G2: LITERATURE SOURCE PATEL, S; ROSENKRANZ, L, HOOKS, B ET AL (2013). HOLMIUM-YTTRIUM ALUMINUM GARNET LASER LITHOTRIPSY IN THE TREATMENT OF BILIARY CALCULI USING SINGLE-OPERATOR CHOL ANGIOSCOPY A MULTICENTER EXPERIENCE. JOURNAL GASTROINTESTINAL ENDOSCOPY. VOL 79, NO 2. DOI.10.1016. 2013.07.054.
RELATED REPORT: THIS REPORT IS RELATED TO 2124215-2025-01126 FOR THE VERSA PULSE CONSOLE REPORT. BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, 07/29/2013, WAS CHOSEN AS THE BEST ESTIMATE BASED ON YEAR THE ARTICLE WAS ACCEPTED. BLOCK G2: LITERATURE SOURCE: PATEL, S; ROSENKRANZ, L, HOOKS, B ET AL (2013). HOLMIUM-YTTRIUM ALUMINUM GARNET LASER LITHOTRIPSY IN THE TREATMENT OF BILIARY CALCULI USING SINGLE-OPERATOR CHOL ANGIOSCOPY A MULTICENTER EXPERIENCE. JOURNAL GASTROINTESTINAL ENDOSCOPY. VOL 79, NO 2. DOI.10.1016. 2013.07.054.
IT WAS REPORTED IN THE JOURNAL GASTROINTESTINAL ENDOSCOPY, THAT A HOLMIUM LASER HAS BEEN USED TO DETERMINATE THE SAFETY AND EFFICACY OF THIS TECHNOLOGY IN PATIENTS WITH DIFFICULT BILE DUCT STONES REFRACTORY TO CONVENTIONAL ENDOSCOPIC METHODS. BETWEEN JULY 2007 AND DECEMBER OF 2009, 69 PATIENTS PRESENT TO PARTICIPATED IN STUDY CENTER FOR LASER LITHOTRIPSY OF BILE DUCT STONES. THE LITHOTRIPSY WAS PERFORMED USING A 365 UM SLIMLINE DISPOSABLE LASER PROBE ALONG WITH THE LUMENIS VERSAPULSE, THE LASER WAS DELIVERED UNTIL ADEQUATE FRAGMENTATION WAS ACHIEVED. COMPLETED REMOVAL OF THE DUCT STONES WAS ACHIEVED IN 67 OF 69 PATIENTS, THE LASER FAILED IN 2 PATIENTS WHO ULTIMATELY REQUIRED BILIARY SURGERY AND ANOTHER PATIENT WHO HAD A STONE OD 21MM WAS EMBEDDED IN THE COMMON BILE DUCT. THE ADVERSE EVENTS RESULTED IN TWO PATIENTS WITH MINOR BLEEDING OF BILE DUCT WALL AND ONE PATIENT WITH MODEL POST ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERCP) PANCREATITIS, THAT FULLY RECOVERED AFTER A CONSERVATIVE MANAGEMENT. THIS EVENT CAPTURES THE SLIMLINE FIBER MENTIONED IN THE ARTICLE.
IT WAS REPORTED IN THE JOURNAL GASTROINTESTINAL ENDOSCOPY, THAT A HOLMIUM LASER HAS BEEN USED TO DETERMINATE THE SAFETY AND EFFICACY OF THIS TECHNOLOGY IN PATIENTS WITH DIFFICULT BILE DUCT STONES REFRACTORY TO CONVENTIONAL ENDOSCOPIC METHODS. BETWEEN JULY 2007 AND DECEMBER OF 2009, 69 PATIENTS PRESENT TO PARTICIPATED IN STUDY CENTER FOR LASER LITHOTRIPSY OF BILE DUCT STONES. THE LITHOTRIPSY WAS PERFORMED USING A 365 UM SLIMLINE DISPOSABLE LASER PROBE ALONG WITH THE LUMENIS VERSAPULSE, THE LASER WAS DELIVERED UNTIL ADEQUATE FRAGMENTATION WAS ACHIEVED. COMPLETED REMOVAL OF THE DUCT STONES WAS ACHIEVED IN 67 OF 69 PATIENTS, THE LASER FAILED IN 2 PATIENTS WHO ULTIMATELY REQUIRED BILIARY SURGERY AND ANOTHER PATIENT WHO HAD A STONE OD 21MM WAS EMBEDDED IN THE COMMON BILE DUCT. THE ADVERSE EVENTS RESULTED IN TWO PATIENTS WITH MINOR BLEEDING OF BILE DUCT WALL AND ONE PATIENT WITH MODEL POST ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERCP) PANCREATITIS, THAT FULLY RECOVERED AFTER A CONSERVATIVE MANAGEMENT. THIS EVENT CAPTURES THE SLIMLINE FIBER MENTIONED IN THE ARTICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1255614 | SLIMLINE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-SLIMLINE_FIBERS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown | Required Intervention |