CONMED 138107Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 30653405003421), received between Nov 14, 2017 and Mar 12, 2026 — classified as 1 injury, 8 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.

• MalfunctionMar 12, 2026Delivered as Unsterile Product

  THIS DISTRIBUTOR REPORTED THAT THE 138107 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 24586184 ↗
• MalfunctionJan 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138107, 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 21208328 ↗
• MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138107, 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 17038680 ↗
• MalfunctionMar 8, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138107, 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 16503556 ↗
• MalfunctionJan 31, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,138107, 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 16273230 ↗
• MalfunctionFeb 17, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138107, 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 13548690 ↗
• MalfunctionJan 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 138107, LOT 202006221, 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; 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 13190839 ↗
• MalfunctionOct 1, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED A TEAR IN THE POUCH. THERE WAS NO PATIENT IMPACT OR INJURY AS IT WAS CAUGHT DURING INCOMING INSPECTION HOWEVER, DUE TO THE TEAR NOT BEING OBVIOUS AND THE BREACH IN STERILITY CONFIRMED. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923409 ↗
• InjuryNov 14, 2017Electrical /Electronic Property Problem; Device Operates Differently Than Expected; Electrical /Electronic Property Problem; Device Operates Differently Than Expected

  THE USER FACILITY REPORTED THAT DURING A COMBINED BILATERAL BREAST AUGMENTATION AND ABDOMINOPLASTY, WHILE CAUTERIZING A SIZZLING NOISE WAS HEARD, AND THE 138107 FLAT BLADE WAS OBSERVED TO HAVE A BLACK RING AROUND THE HUB. THE PATIENT HAD AN AREA THAT WAS REPORTED AS A 2ND DEGREE BURN IN HER UPPER ABDOMEN. THE CAUTERY TIP WAS REMOVED FROM THE FIELD AND A FRESH BLADE AND NEW GENERATOR WHERE USED TO COMPLETE THE PROCEDURE WITH A 10-MINUTE SURGICAL DELAY. UPON CLINICAL ASSESSMENT, THE BURN WAS REPORTED TO HAVE BEEN TREATED WITH A DRESSING. THE PATIENT RECOVERED FROM THE PROCEDURE AS EXPECTED AND WITH NO FURTHER COMPLICATIONS. THE REPORTER ALSO STATED THAT DURING THE PATIENT'S FOLLOW UP APPOINTMENT ON (B)(6) 2017 THE BURN WAS OBSERVED TO HAVE COMPLETELY HEALED. THIS REPORT IS RAISED BASED ON A REPORTED PATIENT INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7030621 ↗