SX-One MicroKnife 600112-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00860002094700), received between Oct 24, 2023 and Jul 29, 2025 — classified as 6 injuries.

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 29, 2022Class IITerminated

   Potential of dull blade

   Z-1387-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INFORMATION OBTAINED FROM THE OPERATING SURGEON, A CTR-US (CARPAL TUNNEL RELEASE USING ULTRASOUND GUIDANCE) WAS PERFORMED IN (B)(6) 2024 FOR SEVERE CTS (CARPAL TUNNEL SYNDROME), INCLUDING PROXIMALLY RADIATING PAIN. THE PROCEDURE WAS UNEVENTFUL WITH NO DEVICE MALFUNCTION. TWO WEEKS POST-OPERATIVELY, THE CTS SYMPTOMS HAD COMPLETELY RESOLVED. HOWEVER, THE PATIENT REPORTED NEW NUMBNESS IN THE 3RD WEBSPACE. THE NUMBNESS PERSISTED AND AN MRI IN (B)(6) 2025 DEMONSTRATED POST-OPERATIVE CHANGES BUT NO OTHER ABNORMALITIES. THE PATIENT EVENTUALLY DEVELOPED SOME IRRITATIVE SYMPTOMS (PARESTHESIAS) ASSOCIATED WITH THE NUMBNESS. AN EXPLORATION USING AN OPEN CARPAL TUNNEL RELEASE APPROACH WAS PERFORMED IN (B)(6) 2025. FOCAL SWELLING (NOTED AS A "KNOT") WAS NOTED, POTENTIALLY INDICATIVE OF A NEUROMA IN CONTINUITY. HOWEVER, THERE WAS NO CLEAR SIGN OF INJURY. THE PHYSICIAN EXCISED THE ENLARGED NERVE SEGMENT AND PERFORMED A CONNECTOR ASSISTED NERVE REPAIR. IN THE EARLY POST-OPERATIVE PERIOD, THE PATIENT'S PARESTHESIAS HAD ALREADY RESOLVED, THOUGH SHE CONTINUED TO HAVE NUMBNESS IN THE THIRD INTERSPACE. THE PHYSICIAN PLANS TO FOLLOW THE PATIENT AND ANTICIPATES SOME RECOVERY OF SENSATION.

  Patient problems: Nerve Damage; Neuropathy; Numbness

  MAUDE report 22643139 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER PERFORMING AN IN-OFFICE CTR PROCEDURE USING ULTRASOUND GUIDANCE, THE PHYSICIAN NOTED GREATER THAN NORMAL BLEEDING FROM THE WOUND. THE BLEEDING WAS CONTROLLED AND THE INCISION CLOSED. THE PATIENT LATER RETURNED TO THE PHYSICIAN'S OFFICE COMPLAINING OF PAIN AND NUMBNESS IN THE SMALL FINGER. THE SURGEON PERFORMED SURGERY TO REPAIR THE ULNAR ARTERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Numbness; Pain; Perforation of Vessels

  MAUDE report 21163931 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ULTRAGUIDECTR PRIMED AND FUNCTIONED NORMALLY DURING THE PROCEDURE ON (B)(6) 2023, AND THE PROCEDURE WAS UNEVENTFUL. THE PHYSICIAN INDICATED THAT HE TOOK MULTIPLE PASSES WITH THE DEVICE TO ENSURE A COMPLETE RELEASE, BUT DID NOT NOTE ANY UNUSUAL DIFFICULTY CUTTING THE LIGAMENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE POST-OPERATIVE COURSE WAS UNEVENTFUL UNTIL 3 WEEKS POST-PROCEDURE, WHEN THE PATIENT HEARD A POP IN THEIR HAND AND WAS HAVING DIFFICULTY NORMALLY BENDING THE RING FINGER. AN EVALUATION WITH DIAGNOSTIC ULTRASOUND CONFIRMED A FLEXOR DIGITORUM SUPERFICIALIS (FDS)-RING FINGER RUPTURE AT THE LEVEL OF THE WRIST CREASE. THE PHYSICIAN EXPLORED AND REPAIRED THE TENDON, AND THE PATIENT IS RECOVERING UNEVENTFULLY. THE PHYSICIAN DID NOT SEE ANYTHING UNUSUAL AT THE TIME OF THE TENDON REPAIR AND THE PATIENT HAD NO OTHER IDENTIFIABLE RISK FACTORS FOR TENDON RUPTURE.

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage

  MAUDE report 18588050 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT-HAND AND LEFT-HAND CARPAL TUNNEL RELEASE USING ULTRAGUIDECTR WITH ULTRASOUND GUIDANCE. 11 DAYS AFTER SURGERY, PATIENT HAD ONSET OF INCREASING PAIN, STIFFNESS AND SWELLING WITH CLEAR FLUID DISCHARGE FROM RIGHT HAND INCISION SITE ONLY. PATIENT STATES THE LEFT HAND IS HEALING WELL WITHOUT ISSUES. THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT FOR EVALUATION CONCERNING FLEXOR TENOSYNOVITIS/INFECTIOUS COMPLICATION OF RIGHT HAND. NO FEVER OR CHILLS. THE PATIENT HAD SUPERFICIAL ABRASION TO RIGHT WRIST 3-4 DAYS PRIOR BY MOVING WOOD. PATIENT REPORTED THAT RIGHT HAND WAS HEALING WELL BUT WOKE UP WITH THE NEW SYMPTOMS: ACUTE ONSET OF SIGNIFICANT PAIN TO RIGHT WRIST AND PALMAR ASPECT OF RIGHT HAND ALONG FOURTH OR FIFTH FLEXOR SHEATH. THE POSSIBILITY THAT THE INFECTIOUS COMPLICATION RESULTED FROM FIREWOOD ABRASION WAS NOTED. OPEN AND DEBRIDEMENT OF RIGHT HAND. ANTIBIOTICS WERE GIVEN. DIAGNOSIS WAS INFECTIOUS FLEXOR TENOSYNOVITIS. NO DEVICE MALFUNCTION WAS REPORTED.

  Patient problems: Fluid Discharge; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17998348 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT HAND CARPAL TUNNEL RELEASE USING ULTRAGUIDECTR WITH ULTRASOUND GUIDANCE. 18 DAYS LATER THE PATIENT WENT TO THE EMERGENCY DEPARTMENT WITH RIGHT HAND WRIST PAIN, A RIGHT WRIST SEROMA AT SITE OF INCISION, AND PAIN WITH EXTENSION OF SMALL FINGER. IRRIGATION AND DRAINAGE WERE PERFORMED AT BEDSIDE. SERRATIA MARCESCENS WAS NOTED, WHICH IS NOT PARTICULARLY COMMON ORGANISM FOR INFECTION AND IS OFTEN CONSIDERED AN OPPORTUNISTIC INFECTION (I.E., AFFECTS PEOPLE WITH INCREASED SUSCEPTIBILITY TO INFECTION). PATIENT WAS ADMITTED FOR IV ANTIBIOTICS, AND THEIR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) MEDICATION WERE HELD. SYMPTOMS IMPROVED BUT DID NOT COMPLETELY RESOLVE. TWO DAYS LATER THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO OPEN THE FLEXOR TENDON SHEATHS OF THE SMALL AND INDEX FINGERS. DIAGNOSIS WAS INFECTIOUS FLEXOR TENOSYNOVITIS. NO DEVICE MALFUNCTION WAS REPORTED.

  Patient problems: Bacterial Infection; Pain; Seroma

  MAUDE report 17998320 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT HAND CARPAL TUNNEL RELEASE USING ULTRAGUIDECTR WITH ULTRASOUND GUIDANCE. 13 DAYS LATER THE PATIENT WENT TO EMERGENCY DEPARTMENT WITH A RIGHT HAND WRIST PAIN, PAIN WITH MOVEMENT, AND RIGHT WRIST SEROMA A SITE OF INCISION (CONFIRMED BY CT). IRRIGATION AND DRAINAGE WERE PERFORMED AT BEDSIDE. METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA) INFECTION NOTED. THE NEXT DAY THE PATIENT WAS PRESENTED TO THE CLINIC WITH SYMPTOMS CONCERNING OF FLEXOR TENOSYNOVITIS OF RIGHT SMALL AND INDEX FINGERS. THE PATIENT WAS ADMITTED FOR IV ANTIBIOTICS. SYMPTOMS IMPROVED BUT DID NOT COMPLETELY RESOLVE. TWO DAYS LATER THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO OPEN THE FLEXOR SHEATHS OF THE SMALL AND INDEX FINGER. MURKY FLUID ENCOUNTERED. NO GROWTH WAS NOTED. DIAGNOSIS WAS INFECTIOUS FLEXOR TENOSYNOVITIS. NO DEVICE MALFUNCTION WAS REPORTED.

  Patient problems: Bacterial Infection; Inflammation; Pain; Seroma

  MAUDE report 17998233 ↗