CONMED 138100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30653405003322), received between Mar 28, 2018 and Feb 26, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 138100 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. THE SHIPMENT ASSOCIATED WITH THE RGA FOR THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AND IT HAS NOT BEEN CONFIRMED THAT AN INSUFFICIENT HEATSEAL CAUSING A STERILITY BREACH HAS OCCURRED. BASED ON THE INFORMATION AVAILABLE, AND THE DECISION TREE RESULTS, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. UPON THE RECEIPT OF THE DEVICE, AN EVALUATION WILL BE CONDUCTED AND IF A BREACH OF STERILITY IS CONFIRMED THE REPORTING DECISION WILL BE REASSESSED AT THAT TIME. UPDATE: THE DEVICE WAS RETURNED AND EVALUATED. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT HAS BEEN REASSESSED AND MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468690 ↗
• MalfunctionJan 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572687 ↗
• MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037697 ↗
• MalfunctionFeb 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,138100, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279062 ↗
• MalfunctionNov 7, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 138100, LOT 201909301, 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 JAPAN. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758907 ↗
• MalfunctionMay 26, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, ELECTRODE BLADE STD COINED, CATALOG # 138100, LOT 201909091, 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 DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887429 ↗
• MalfunctionMay 26, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, ELECTRODE BLADE STD COINED, CATALOG # 138100, LOT 201909031, 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 DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887306 ↗
• MalfunctionOct 24, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THAT THE 138100, UNIVERSAL DISPOSABLE ELECTRODE, APPEARED TO HAVE A TEAR IN THE PACKAGING. A DYE LEAK TEST WAS PERFORMED AND CONFIRMED THERE WAS A STERILITY BREACH. THIS REPORT SI BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000310 ↗
• MalfunctionMar 28, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR IN (B)(6) REPORTED A "TEAR" ON THE STERILE POUCH OF DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7379011 ↗