Electrosurgical Tip Cleaner; PLRecalls & reported problems across all models

We found 2 models of Electrosurgical Tip Cleaner; PL by Xodus Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 24, 2021 and Aug 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

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

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

Electrosurgical Tip Cleaner; PL 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. Sep 19, 2019Terminated

   The sterile barrier of some devices may have been affected

   Z-0150-2020 · Root cause: Packaging · Recall details · FDA record ↗

2. Sep 19, 2019Terminated

   The sterile barrier of some devices may have been affected

   Z-0149-2020 · Root cause: Packaging · Recall details · FDA record ↗

Most reported Electrosurgical Tip Cleaner; PL problems

Electrosurgical Tip Cleaner; PL models

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

• Electrosurgical Tip Cleaner; PL 138029

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 recall2 reports
• Electrosurgical Tip Cleaner; PL 62-8499-001

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 recall0 reports

Recent Electrosurgical Tip Cleaner; PL adverse event reports

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

• MalfunctionAug 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS IS A VOLUNTARY DISTRIBUTOR REPORT DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 138029 LOT 19MAR14A, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE PRELIMINARY DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387379 ↗
• MalfunctionMay 24, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS IS A VOLUNTARY DISTRIBUTOR REPORT. DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, ELECTROSURGICAL TIP CLEANER, CATALOG 138029, LOT 19FEB27 FOR A POSSIBLE INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN JAPAN. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873050 ↗