NA 214646Recalls & reported problems

Summary

The FDA's MAUDE database contains 361 adverse event reports that list this exact device (DI 10886705004270), received between May 21, 2018 and Sep 25, 2026 — classified as 361 malfunctions.

The most frequently reported specific device problem is “Degraded” (175 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 361 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Mechanical Jam

  It was reported that during an unspecified surgical procedure, during drilling with the GRYPHON 2.4MM DRILL BIT device it was observed that the drill was not very sharp. It was reported that the surgeon continued with the same drill bit device, as there was no other option. It was reported that when the surgeon went to cut the suture with the CORDCUTTER device, the cutter device kept jamming, and the surgeon continued with the same device as there was no other option. It was reported that there was no delay in the procedure due to the event. It was reported that there was no harm to the patient or the user. All available information has been disclosed. No additional information has been provided. This is report 1 of 2 for PC-(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896810 ↗
• MalfunctionJun 30, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE CORDCUTTER DEVICE WILL NOT CUT AND RETURN TO OPEN POSITION (STUCK). ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667962 ↗
• MalfunctionJun 1, 2026Break; Degraded; Mechanical Jam

  IT WAS REPORTED THAT DURING PRODUCT INSPECTION OF THE CORDCUTTER *EA DEVICE IT WAS FOUND THAT THERE WAS NO PLAY BETWEEN THE CUTTER, INNER CYLINDER, AND GUIDE, MAKING IT EXTREMELY STIFF TO GRIP, AND THE TRIGGER WAS ALSO VERY STIFF TO OPEN. IT WAS REPORTED THAT THE INNER CYLINDER SHOWED SIGNS OF FRICTION AND METAL SHAVINGS. THE SURGEON POINTED OUT THAT THE CUTTING PERFORMANCE WAS POOR, THE TOOL WAS STIFF AND DIFFICULT TO OPERATE, AND THAT THE EXCESSIVE STIFFNESS MIGHT INDICATE A STRUCTURAL PROBLEM. THE SURGEON STATED THAT THE PRODUCT IN QUESTION COULD NOT BE USED FOR SURGERY. THE DEVICE WAS NOT USED IN A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350858 ↗
• MalfunctionMar 25, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY PERFORMED ON AN UNKNOWN DATE, THE SALES REP RECEIVED A CALL FROM THE DISTRIBUTOR AND STATED THAT THE SURGEON WAS HAVING TROUBLE USING THE CORD CUTTER THE HOSPITAL PURCHASED, BECAUSE THE LEVER IS TOO STIFF. THE HOSPITAL WANTED A REPLACEMENT WITH A NEW ONE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689454 ↗
• MalfunctionMar 24, 2026Degraded; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LEVER OF THE CORDCUTTER DEVICE WAS STIFF AND WAS DIFFICULT TO CUT WITH. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675829 ↗
• MalfunctionMar 16, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE CORDCUTTER DEVICE WAS JAMMING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607847 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE CORDCUTTER DEVICE HAD AN INTERNAL PIECE BROKE OUT OF IT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586583 ↗
• MalfunctionMar 2, 2026Degraded; Mechanical Jam

  IT WAS REPORTED THAT THE CORDCUTTER *EA DEVICE WAS DIFFICULT TO CUT WITH A LOT OF RESISTANCE WHEN THE USER TRIED TO TEST CUT WITH IT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489798 ↗
• MalfunctionFeb 25, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE HANDLE OF THE CORDCUTTER DEVICE WAS TOO STIFF AND DIFFICULT TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS USED FOR THE FIRST TIME AFTER PURCHASE. THERE WERE 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445557 ↗
• MalfunctionDec 17, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE CORDCUTTER DEVICE CUT WAS BAD. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832343 ↗
• MalfunctionDec 15, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CORDCUTTER DEVICE DOES NOT CUT. THERE WERE NO REPORTS OF DELAYS TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804806 ↗
• MalfunctionDec 4, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON SHOULDER JOINT FOR ROTATOR CUFF TEAR, THE CORDCUTTER MOVEMENT WAS POOR, AND IT COULD NOT BE USED. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720664 ↗
• MalfunctionNov 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY PERFORMED ON SHOULDER JOINT FOR ROTATOR CUFF TEAR, IT WAS OBSERVED THAT THE CORDCUTTER DEVICE MOVEMENT WAS POOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630344 ↗
• MalfunctionNov 6, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE TIP ON THE CORDCUTTER DEVICE ¿DID NOT MESH WELL¿. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485138 ↗
• MalfunctionOct 23, 2025Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING DEVICE OPERATION CHECK UPON DELIVERY, IT WAS OBSERVED THAT THE CORDCUTTER DEVICE HANDLE WAS NOT SMOOTH. IT WAS REPORTED THAT BECAUSE IT WAS CONFIRMED BEFORE CLINICAL USE, THE DEVICE WAS NOT USED ON THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS USING THE EXISTING DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HANDLE AND LOCK LEVER WAS PRESSED SEVERAL TIMES, AND A HIGH RESISTANCE WAS FELT ON BOTH OPENING AND CLOSING OF THE DEVICE MECHANISM. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367403 ↗
• MalfunctionOct 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE CORDCUTTER DEVICE HANDLE IS STUCK AND WON'T DISENGAGE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301751 ↗
• MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INNER CYLINDER OF THE CORDCUTTER DEVICE CAME OFF. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983655 ↗
• MalfunctionSep 4, 2025Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE HANDLES OF THE CORDCUTTER DEVICE DID NOT RETURN TO THEIR ORIGINAL POSITIONS AFTER CUTTING A SUTURE SINCE THE MOVEMENT OF THE HANDLES WAS STIFF. ACCORDING TO THE REPORTER, THE SURGEON COULD ONLY OPEN THE DEVICE BY PULLING THE HANDLES WITH BOTH HANDS. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962751 ↗
• MalfunctionAug 13, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE CORDCUTTER DEVICE CUT WAS BAD. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796302 ↗
• MalfunctionAug 13, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MOVEMENT OF THE CORDCUTTER DEVICE WAS STIFF. IT WAS REPORTED THAT AFTER THE SURGERY, THE DEVICE WAS CHECKED AGAIN, AND THE MOVEMENT WAS STILL STIFF. IT WAS NOTED THAT WHEN OPENING AND CLOSING THE DEVICE WITHOUT THE INNER SHAFT, THE MOVEMENT WAS NOT STIFF, BUT WHEN THE INNER SHAFT WAS INSERTED, THE DEVICE BECAME STIFF. IT WAS REPORTED THAT THERE WAS A LESS THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794246 ↗
• MalfunctionAug 13, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE SURGEON USED THE CORDCUTTER DEVICE FOR CUTTING SUTURES, BUT THE STAINLESS TRIGGER PART WAS STIFF AND IT WAS DIFFICULT TO CUT SUTURES. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791433 ↗
• MalfunctionAug 12, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE CORDCUTTER EA DEVICE "BECAME POORLY CUT" WOULD CUT POORLY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787353 ↗
• MalfunctionAug 6, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE CUTTER ON THE CORDCUTTER DEVICE WAS BAD. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729570 ↗
• MalfunctionJul 29, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN TRYING TO PUT THE CORDCUTTER EA DEVICE TOGETHER IT WAS DISCOVERED THAT THE HOOK END OF THE INSERT WAS BENT. THE USER COULD GET IT TOGETHER BUT IT WOULD NOT WORK PROPERLY. THERE WAS NO DELAY REPORTED TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645120 ↗
• MalfunctionJul 29, 2025Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT IT WAS DIFFICULT FOR THE SUTURE TO SLIDE DOWN THE CORDCUTTER EA DEVICE AS DESIGNED. IT LOOKED LIKE THE CUTTING END WAS BENT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644441 ↗