Hydratome RX 49Recalls & reported problems across all models

We found 2 models of Hydratome RX 49 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2019 and Jul 17, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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

Hydratome RX 49 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. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0764-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Dec 22, 2021Open, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0763-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported Hydratome RX 49 problems

Hydratome RX 49 models

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

• Hydratome RX 49 M00583010

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall2 reports
• Hydratome RX 49 M00583000

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports

Recent Hydratome RX 49 adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 49 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE CUTTING WIRE OF THE HYDRATOME RX 49 BROKE OFF. REPORTEDLY, AN EXTRACTOR PRO DEVICE WAS USED TO CLEAN THE BILE DUCT AND RETRIEVE THE BROKEN PIECE; HOWEVER, THEY WERE NOT ABLE TO FIND THE DETACHED PIECE. THE PROCEDURE WAS COMPLETED WITH THE EXTRACTOR PRO. IN THE PHYSICIAN'S ASSESSMENT, THE CUTTING WIRE PASSED THOUGH THE MAIN BILE DUCT. A SYSTEMATIC SCANNER WAS SCHEDULED TO TAKE PLACE A MONTH FOLLOWING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799009 ↗
• MalfunctionJun 5, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 49 WAS USED DURING A SPHINCTEROTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE CUTTING WIRE BROKE DURING SPHINCTEROTOMY. ADDITIONALLY, A PHOTO OF THE DEVICE WAS PROVIDED WHICH SHOWED THAT THE CUTTING WIRE WAS ALSO KINKED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8670110 ↗

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