ORISE GelRecalls & reported problems across all models

We found 4 models of ORISE Gel by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Apr 29, 2022 and Dec 23, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ORISE Gel recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 10, 2022Open, Classified

   ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

   Z-0225-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Oct 10, 2022Open, Classified

   ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

   Z-0224-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported ORISE Gel problems

ORISE Gel models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORISE™ Gel M00519220

  Submucosal injection agent
  1 recall2 reports
• ORISE™ Gel M00519200

  Submucosal injection agent
  1 recall1 report
• ORISE™ Gel M00519210

  Submucosal injection agent
  1 recall0 reports
• ORISE™ Gel M00519230

  Submucosal injection agent
  1 recall0 reports

Recent ORISE Gel adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2022Nonstandard Device

  RECEIVED A RECALL NOTICE FOR BOSTON SCIENTIFIC'S ORISE GEL GTIN: (B)(4), REF: (B)(4). LOT: 29313438.

  Patient problems: Insufficient Information

  MAUDE report 16051329 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED IN (B)(6) 2021. IN (B)(6) 2022, A POSITRON EMISSION TOMOGRAPHY (PET) SCAN WAS PERFORMED TO EVALUATE A LUNG NODULE FOR A SEPARATE ISSUE. THE PET SCAN SHOWED A "HOT SPOT" IN THE DUODENUM AT THE SAME LOCATION AS THE ESD PERFORMED IN (B)(6) 2021. IT WAS STATED THAT THE PHYSICIAN ATTRIBUTED THIS FINDING TO ORISE INFLAMMATION. AS A RESULT OF THE FINDINGS ON THE PET SCAN, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH BIOPSY IN (B)(6) 2022. THE BIOPSY SHOWED "PEPTIC DUODENITIS WITH ULCERATION".

  Patient problems: Inflammation

  MAUDE report 15655131 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORISE PROKNIFE AND ORISE GEL WAS USED IN THE COLON DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE PERFORMED ON (B)(6) 2022. NEAR THE END OF THE PROCEDURE, THE PATIENT CODED. CODE BLUE PROTOCOL WAS IMPLEMENTED AND THE PATIENT WAS RESUSCITATED. THE PATIENT WAS BROUGHT TO SURGERY TO REPAIR A SMALL PERFORATION IN THE ASCENDING COLON, WHICH WAS SUCCESSFULLY TREATED WITH A CLIP. THE PATIENT DECOMPENSATED OVER THE NEXT FEW DAYS AND DIED ON (B)(6) 2022. THE PATIENT HAD MULTIPLE COMORBIDITIES AND THE FAMILY DECIDED NOT TO CONTINUE LIFE SUPPORT. NO AUTOPSY WAS PERFORMED, HOWEVER THE CLINICAL CAUSE OF DEATH WAS REPORTED TO BE BRAIN DAMAGE. THE PHYSICIAN DEEMED THE PATIENT'S DEATH TO BE NOT RELATED TO THE ORISE DEVICES AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 14256037 ↗

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