CONMED 138104Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 30653405003391), received between Mar 1, 2018 and Jun 11, 2026 — classified as 57 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (52 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Delivered as Unsterile Product

  THIS DISTRIBUTOR REPORTED THAT THE 139104EXT DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. 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 25470674 ↗
• MalfunctionMar 12, 2026Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, (B)(6), FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580285 ↗
• MalfunctionMar 12, 2026Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, (B)(6) FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. 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 24578601 ↗
• MalfunctionMar 12, 2026Delivered as Unsterile Product

  THIS DISTRIBUTOR REPORTED THAT THE 138104 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. 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 24578393 ↗
• MalfunctionMar 12, 2026Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104 FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. 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 24578367 ↗
• MalfunctionDec 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 138104 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. 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 23830686 ↗
• MalfunctionDec 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 138104 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. 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 23809818 ↗
• MalfunctionDec 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 138104 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. 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 23777552 ↗
• MalfunctionDec 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 23777204 ↗
• MalfunctionDec 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 23777145 ↗
• MalfunctionDec 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 23767433 ↗
• MalfunctionSep 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE 138104 ACCESSORY ELECTRODE, FLAT BLADE WITH EXTENDED INSULATION, 10FR W/CONTROL VENT & OBTURATOR, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036633 ↗
• MalfunctionAug 1, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE 138104, ACCESSORY ELECTRODE,FLAT BLADE WITH EXTENDED INSULATION, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685247 ↗
• MalfunctionJun 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 22150370 ↗
• MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, ACCESSORY ELECTRODE, FLAT BLADE WITH EXTENDED INSULATION, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911833 ↗
• MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. 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 21911593 ↗
• MalfunctionApr 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, ACCESSORY ELECTRODE,FLAT BLADE WITH EXTENDED INSULATION, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911061 ↗
• MalfunctionMar 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 138104 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 NOT RETURNED FOR EVALUATION; THEREFORE, THIS COMPLAINT 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 21631911 ↗
• MalfunctionMar 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR REPORTED THAT THE 138104 DEVICES 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 NOT RETURNED FOR EVALUATION; THEREFORE, THIS COMPLAINT 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 21620097 ↗
• MalfunctionDec 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 20852305 ↗
• MalfunctionNov 27, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 20797328 ↗
• MalfunctionMar 29, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 19003097 ↗
• MalfunctionOct 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, 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 17983864 ↗
• MalfunctionOct 18, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959777 ↗
• MalfunctionOct 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138104, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. . PERFORMED A VISUAL INSPECTION OF THE DEVICE, THERE WERE NO OBVIOUS SIGNS OF A BREACH IN THE SEAL HOWEVER, THE DEVICE WAS ENCROACHING INTO THE SEAL. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919600 ↗