ACUPULSE
Report
- Report Number
- 2124215-2025-44081
- Event Type
- Injury
- Date Received
- July 8, 2025
- Date of Event
- June 24, 2025
- Report Date
- October 24, 2025
- Manufacturer
- LUMENIS LTD
- Product Code
- GEX
- PMA / PMN Number
- K180597
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CITATION: VIRGINIA FANCELLO, ANDREA MIGLIORELLI, ANDREA CAMPOMAGNANI, FEDERICA MOROLLI. (2024). SURGICAL AND FUNCTIONAL OUTCOMES OF POSTERIOR CORDOTOMY AND PARTIAL ARYTENOIDECTOMY WITH CO2 LASER IN THE TREATMENT OF BILATERAL VOCAL CORD IMMOBILITY: A SINGLE INSTITUTION EXPERIENCE. JOURNAL OF CLINICAL MEDICINE., 2024 (13), 3670.
THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF SWALLOWING DISORDERS, RESTENOSIS, SPEECH DISORDERS AND GRANULOMA ARE A KNOWN RISK ASSOCIATED WITH 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. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CITATION: VIRGINIA FANCELLO, ANDREA MIGLIORELLI, ANDREA CAMPOMAGNANI, FEDERICA MOROLLI. (2024). SURGICAL AND FUNCTIONAL OUTCOMES OF POSTERIOR CORDOTOMY AND PARTIAL ARYTENOIDECTOMY WITH CO2 LASER IN THE TREATMENT OF BILATERAL VOCAL CORD IMMOBILITY: A SINGLE INSTITUTION EXPERIENCE. JOURNAL OF CLINICAL MEDICINE., 2024 (13), 3670.
IT WAS REPORTED IN THE JOURNAL OF CLINICAL MEDICINE THAT A STUDY WAS CONDUCTED TO INVESTIGATE SURGICAL AND FUNCTIONAL OUTCOMES OF PATIENTS AFFECTED BY BILATERAL VOCAL CORD IMMOBILITY (BVCI) AND TREATED WITH POSTERIOR CORDOTOMY AND PARTIAL ARYTENOIDECTOMY. A TOTAL OF 27 PATIENTS AFFECTED BY BVCI AND TREATED WITH POSTERIOR CORDOTOMY AND PARTIAL ARYTENOIDECTOMY WERE ENROLLED FROM JANUARY 2017 TO JANUARY 2022. THE FOLLOWING BOSTON SCIENTIFIC PRODUCT WAS USED DURING THE PROCEDURES: ACUPULSE. PRE-OPEREATIVELY ANALYSIS INDICATES 15 PATIENTS DEVELOPED A THYROID DISEASE. REGARDING POSTOPERATIVE COMPLICATIONS, 2 PATIENTS WHO EXPERIENCED BCVI AFTER A STROKE HAVE NOT EXPERIENCED DECANNULATION. AFTER THE SURGERY, AN OVERALL WORSENING IN VOICE QUALITY WAS PERCEIVED IN SOME PATIENTS. TWO PATIENTS REPORTED MECHANICAL BCVI FOLLOWING ADMISSION TO THE INTENSIVE CARE UNIT AND PROLONGED ENDOTRACHEAL INTUBATION DURING COVID19 INFECTION, BOTH PATIENTS HAD BEEN ALREADY TRACHEOSTOMIZED. DURING THE SARS-COV-2 PANDEMIC, THERE WAS A HIGH RATE OF ENDOTRACHEAL INTUBATION IN PATIENTS WHO DEVELOPED INTERSTITIAL PNEUMONIA. ACCORDING TO THE RESULTS, POSTERIOR CORDOTOMY PLUS PARTIAL ARYTENOIDECTOMY IS AN EFFECTIVE PROCEDURE THAT PROVIDES STABLE AND RAPID RESPIRATORY IMPROVEMENT WHILST PRESERVING SWALLOWING AND SELF-PERCEPTION OF VOICE QUALITY.
IT WAS REPORTED IN THE JOURNAL OF CLINICAL MEDICINE THAT A STUDY WAS CONDUCTED TO INVESTIGATE SURGICAL AND FUNCTIONAL OUTCOMES OF PATIENTS AFFECTED BY BILATERAL VOCAL CORD IMMOBILITY (BVCI) AND TREATED WITH POSTERIOR CORDOTOMY AND PARTIAL ARYTENOIDECTOMY. A TOTAL OF 27 PATIENTS AFFECTED BY BVCI AND TREATED WITH POSTERIOR CORDOTOMY AND PARTIAL ARYTENOIDECTOMY WERE ENROLLED FROM JANUARY 2017 TO JANUARY 2022. THE FOLLOWING BOSTON SCIENTIFIC PRODUCT WAS USED DURING THE PROCEDURES: ACUPULSE. PRE-OPEREATIVELY ANALYSIS INDICATES 15 PATIENTS DEVELOPED A THYROID DISEASE. REGARDING POSTOPERATIVE COMPLICATIONS, 2 PATIENTS WHO EXPERIENCED BCVI AFTER A STROKE HAVE NOT EXPERIENCED DECANNULATION. AFTER THE SURGERY, AN OVERALL WORSENING IN VOICE QUALITY WAS PERCEIVED IN SOME PATIENTS. TWO PATIENTS REPORTED MECHANICAL BCVI FOLLOWING ADMISSION TO THE INTENSIVE CARE UNIT AND PROLONGED ENDOTRACHEAL INTUBATION DURING COVID19 INFECTION, BOTH PATIENTS HAD BEEN ALREADY TRACHEOSTOMIZED. DURING THE SARS-COV-2 PANDEMIC, THERE WAS A HIGH RATE OF ENDOTRACHEAL INTUBATION IN PATIENTS WHO DEVELOPED INTERSTITIAL PNEUMONIA. ACCORDING TO THE RESULTS, POSTERIOR CORDOTOMY PLUS PARTIAL ARYTENOIDECTOMY IS AN EFFECTIVE PROCEDURE THAT PROVIDES STABLE AND RAPID RESPIRATORY IMPROVEMENT WHILST PRESERVING SWALLOWING AND SELF-PERCEPTION OF VOICE QUALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1857202 | ACUPULSE | POWERED LASER SURGICAL INSTRUMENT | GEX | LUMENIS LTD | UNK-P-ACUPULSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |