ORISE PROKNIFE
Report
- Report Number
- 3005099803-2022-07547
- Event Type
- Injury
- Date Received
- December 14, 2022
- Date of Event
- December 1, 2022
- Report Date
- February 21, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K200404
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORT SOURCE: LITERATURE. THE CITATION OF THE JOURNAL ARTICLE IS BELOW. DR. GALEN LEUNG IS THE AUTHOR. DOI: 10.1200/JCO.2022.40.4_SUPPL.103 JOURNAL OF CLINICAL ONCOLOGY 40, NO. 4_SUPPL (FEBRUARY 01, 2022) 103-103.
BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1, G2: REPORT SOURCE: LITERATURE. THE CITATION OF THE JOURNAL ARTICLE IS BELOW. DR. GALEN LEUNG IS THE AUTHOR. DOI: 10.1200/JCO.2022.40.4_SUPPL.103 JOURNAL OF CLINICAL ONCOLOGY 40, NO. 4_SUPPL (FEBRUARY 01, 2022) 103-103.
PER LITERATURE, A STUDY WAS PERFORMED TO TEST THE TECHNICAL FEASIBILITY OF SALVAGE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AFTER CHEMORADIATION FOR LOCALLY ADVANCED RECTAL ADENOCARCINOMA. A RETROSPECTIVE CHART REVIEW OF CASES OF SALVAGE ESD FOR LOCALLY ADVANCED RECTAL CANCER AND STANDARD ESD FOR RECTAL TUMORS WITHOUT PRIOR CHEMORADIATION FROM JULY 2018 TO AUGUST 2020 WAS PERFORMED. ELECTROSURGERY WAS PERFORMED WITH EITHER THE 1.5-MM OR 3-MM ORISE PROKNIFE (BOSTON SCIENTIFIC) OR 2-MM DUALKNIFE J (OLYMPUS AMERICA). IT WAS NOT SPECIFIED WHICH KNIFE WAS USED FOR THESE TWO ADVERSE EVENTS. REPORTEDLY, TWO ADVERSE EVENTS OCCURRED INVOLVING ACUTE POSTPROCEDURAL BLEEDING WITHIN A FEW DAYS OF THE PROCEDURE. THESE PROMPTED REPEAT INTERVENTIONAL ENDOSCOPY PROCEDURES AND RESOLUTION OF BLEEDING. IT IS UNKNOWN WHAT THE EXACT CAUSE OF THE BLEED WAS.
PER LITERATURE, A STUDY WAS PERFORMED TO TEST THE TECHNICAL FEASIBILITY OF SALVAGE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AFTER CHEMORADIATION FOR LOCALLY ADVANCED RECTAL ADENOCARCINOMA. A RETROSPECTIVE CHART REVIEW OF CASES OF SALVAGE ESD FOR LOCALLY ADVANCED RECTAL CANCER AND STANDARD ESD FOR RECTAL TUMORS WITHOUT PRIOR CHEMORADIATION FROM JULY 2018 TO AUGUST 2020 WAS PERFORMED. ELECTROSURGERY WAS PERFORMED WITH EITHER THE 1.5-MM OR 3-MM ORISE PROKNIFE (BOSTON SCIENTIFIC) OR 2-MM DUALKNIFE J (OLYMPUS AMERICA). IT WAS NOT SPECIFIED WHICH KNIFE WAS USED FOR THESE TWO ADVERSE EVENTS. REPORTEDLY, TWO ADVERSE EVENTS OCCURRED INVOLVING ACUTE POSTPROCEDURAL BLEEDING WITHIN A FEW DAYS OF THE PROCEDURE. THESE PROMPTED REPEAT INTERVENTIONAL ENDOSCOPY PROCEDURES AND RESOLUTION OF BLEEDING. IT IS UNKNOWN WHAT THE EXACT CAUSE OF THE BLEED WAS. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 13, 2023: NONE OF THE ADVERSE EVENTS WERE DUE TO THE ORISE PROKNIFE, AS THE ADVERSE EVENTS IN THE DATASET OCCURRED BEFORE THE ACCOUNT HAD STARTED TO USE THE ORISE PROKNIFE AT THEIR INSTITUTION. THE ADVERSE EVENTS THAT WERE REPORTED WERE IN THE TIMEFRAME OF JULY 2018 TO DECEMBER 2019, WHICH CORRESPONDS TO THE TIME WHEN THE DUALKNIFE WAS EXCLUSIVELY USED. THEREFOR THIS IS NO LONGER A REPORTABLE EVENT AGAINST THE ORISE PROKNIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2141974 | ORISE PROKNIFE | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |