GenCut SDCT01 (UDI 10884521539716)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521539716), received between Sep 20, 2016 and Apr 14, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Kinked” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE, THE STUDY WAS ABOUT THE EXPERIENCE OF ULTRATHIN PROBE TRANSBRONCHIAL LUNG CRYOBIOPSY (UP-TBLC) VIA THE MONARCH ROBOTIC-ASSISTED BRONCHOSCOPY (RAB) SYSTEM FOR THE DIAGNOSIS OF PPLS WITH PRIMARY ENDPOINTS OF SAFETY AND FEASIBILITY. THIS WAS A RETROSPECTIVE REVIEW OF 58 LESIONS IN 53 PATIENTS THAT UNDERWENT RAB WITH RADIAL PROBE ENDOBRONCHIAL ULTRASONOGRAPHY (RP-EBUS) GUIDED UP-TBLC, COMPLIMENTING TRADITIONAL SAMPLING METHODS OF PPLS DURING SINGLE USER¿S FIRST ADOPTION OF RAB BETWEEN JUNE 2022 AND NOVEMBER 2022.UNDER GENERAL ANESTHESIA VIA AN ENDOTRACHEAL TUBE, MONARCH, RAB WITH RP-EBUS LESION CONFIRMATION WAS PERFORMED. TISSUE ACQUISITION WAS OBTAINED FOR ALL LESIONS IN THE FOLLOWING SEQUENCE: 21 GAUGE NEEDLE BIOPSY AND 15G BIOPSY CORING TOOL ASPIRATIONS, 1.1 MM UP-TBLC, FORCEPS BIOPSY AND BRONCHOALVEOLAR LAVAGE (BAL). THREE INCIDENTS OF PNEUMOTHORAX (5%) OCCURRED. ALL REQUIRED INTERVENTIONS. ONE WAS DISCHARGED ON THE SAME DAY WITHOUT SMALL BORE CHEST TUBE (SBCT) AFTER SUCCESSFUL MANUAL ASPIRATION, ONE DISCHARGED WITH SBCT FOR AMBULATORY MANAGEMENT AND ONE HOSPITALIZED WITH SBCT AFTER FAILING MANUAL ASPIRATION. BOTH CHEST TUBES WERE REMOVED WITHIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 16746942 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT PRESENTED WITH DIFFUSE SPICULATED NODULE IN THE RIGHT LOWER LUNG (RLL) NEAR THE DIAPHRAGM AND ON THE LOWER LUNG (LL) FISSURE. THE SURGEON WAS ABLE TO ACCESS THE LESION AND UPDATE ACCORDINGLY WITH FLUORONAVIGATION. THE USER SAMPLED THE LESION WITH NEEDLE, GENCUT, AND BRUSHES (INCLUDING TRIPLE NEEDLE BRUSH). A DIAGNOSIS OF INFLAMMATION AND NEUTROPHILIC CELLS WERE RECEIVED. THE PATIENT HAD PNEUMOTHORAX THAT REQUIRED A CHEST TUBE. PATIENT WAS ABLE TO GO HOME THE SAME DAY AND HAVE CHEST TUBE REMOVED WITH NO FURTHER ISSUES.

  Patient problems: Pneumothorax

  MAUDE report 15252938 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, PATIENT BLEEDING OCCURRED. THE CASE WAS COMPLETED HOWEVER, PATIENT HOSPITALIZATION WAS EXTENDED.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8551401 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A NAVIGATION, THE PHYSICIAN NOTICED AN ABNORMAL BLOOD ACCUMULATION IN THE LUNG AFTER THE THIRD BIOPSY PASS. THE PHYSICIAN BELIEVES SHE STRUCK THE PULMONARY ARTERY. THE BLEEDING WAS STOPPED. HOWEVER, AFTERWARDS THE PATIENT NEEDED A BLOOD TRANSFUSION AND WAS HOSPITALIZED. THERE WAS NO REPORTED ISSUE WITH THE PRODUCT.

  Patient problems: Blood Loss

  MAUDE report 8154724 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE PATIENT EXPERIENCED BLEEDING. THE PATIENT HAD A 1600CC BLEED AND GOT 3 UNITS OF BLOOD AND 3 UNITS OF PLATELETS. THE PHYSICIAN ATTRIBUTED THE BLEEDING TO THE PATIENT CONDITION WHO WAS VERY SICK AND DID NOT ATTRIBUTE THE BLEEDING TO THE DEVICE.

  Patient problems: Blood Loss

  MAUDE report 8051002 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING DURING A PROCEDURE. IMMEDIATELY AFTER THE FIRST PASS OF THE DEVICE, THERE WAS ARTERIAL BLEEDING DUE TO NEOVASCULARIZATION OF THE NECROTIC TUMOR WHICH WAS SLICED, AS WELL AS PLATELET DYSFUNCTION CAUSED BY NON STEROIDAL ANTI-INFLAMMATORY MEDICATION. THEY TURNED THE PATIENT TO THE SIDE AND INTRODUCED EPINEPHRINE AND ICED SALINE. THEY ALSO DID OCCLUSION WITH SCOPE AND SUCTION. THE BLEEDING STOPPED AND THE AIRWAY WAS CLEARED. THE PATIENT WAS TRANSFERRED TO POST ANESTHESIA CARE UNIT AND EXTUBATED. THEY RE-INTUBATED 15 MINUTES LATER WITH HYPERCAPNIA AND ALTERED MENTAL STATE. IT WAS FOUND THAT THE PATIENT HAD ACUTE MYOCARDIAL INFARCTION. THE COURSE WAS PROLONGED IN INTENSIVE CARE UNIT AND DEVELOPED PNEUMONIA DURING RE-INTUBATION. PALLIATIVE CARE WAS CARE. THERE WAS NO REPORTED DEVICE ISSUE.

  Patient problems: Blood Loss

  MAUDE report 7267151 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING DURING THE PROCEDURE. THERE WAS BLEEDING FROM THE BLOOD VESSELS NEXT TO INFLAMMATORY NODULE. THEY TURNED PATIENT ON THE SIDE AND OCCLUDED THE AIRWAY WITH THE BRONCHOSCOPE. THEY INTRODUCED ICED SALINE AND EPINEPHRINE AND THE BLEEDING STOPPED AFTER 15 MINUTES. THEY EXTUBATED THE PATIENT AND DISCONTINUE INTERVENTION WITHOUT ISSUES. THERE WAS NO ISSUES WITH THE SYSTEM REPORTED. THE PATIENT WAS ASYMPTOMATIC AT FOLLOW UP.

  Patient problems: Blood Loss

  MAUDE report 7266874 ↗
• InjuryJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED WHEN WITHDRAWING THE GENCUT CORE BIOPSY NEEDLE, A GUSH OF BLOOD WAS NOTICED IN THE ASPIRATION SYRINGE. THE PROCEDURE WAS ABORTED AS IT WAS COMPLICATED BY MASSIVE BLEEDING." NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Blood Loss

  MAUDE report 6607539 ↗
• InjuryMay 26, 2017Kinked; Kinked

  A PATIENT RECEIVED A PNEUMOTHORAX DURING A SUPERDIMENSION ENB PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN REPORTED THE GENCUT TWISTED AND KINKED AND WAS UNABLE TO BE PULLED BACK INTO THE CATHETER AND SCOPE. IT HAD TO BE RETRACTED AS ONE WHOLE UNIT.

  Patient problems: Pneumothorax

  MAUDE report 6593484 ↗
• InjurySep 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED A LEFT IATROGENIC PNEUMOTHORAX DURING A SUPERDIMENSION ENB PROCEDURE. PATIENT HAD POST-OP SOB & CHEST PAIN. THE INITIAL CHEST X-RAY SHOWED SMALL 10% PNEUMOTHORAX AND IT PROGRESSED TO 50%. A CHEST TUBE WAS INSERTED AND THE PATIENT WAS ADMITTED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED ON (B)(6) 2016 & THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2016.

  Patient problems: Pneumothorax

  MAUDE report 5962717 ↗