SPiN Thoracic Navigation System, 120V, 60Hz SYS-4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00815686020101), received between Nov 2, 2018 and Feb 12, 2024 — classified as 1 death, 21 injuries, 6 malfunctions.

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

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 10, 2023Class IIOpen, Classified

   Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

   Z-2659-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 13, 2022Class IIOpen, Classified

   A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

   Z-1103-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Failure to Power Up; Failure to Power Up

  A VERAN REPRESENTATIVE CONTACTED VERAN CUSTOMER SUPPORT (VSUPPORT) ON BEHALF OF THE USER AND REPORTED THAT THE SYS-4000 WOULD NOT TURN ON WHEN THE SYSTEM WAS POWERED ON. THE SYSTEM HAD TO BE OPENED UP AND THE POWER BUTTON ON THE CENTRAL PROCESSING UNIT (CPU) HAD TO BE PRESSED TO TURN THE SYSTEM ON. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689270 ↗
• MalfunctionSep 8, 2023Loss of Power; Loss of Power

  THE PLANNED PROCEDURE WAS A DIAGNOSTIC, NAVIGATIONAL BRONCHOSCOPY. THE USERS ATTEMPTED TO TROUBLESHOOT THE DEVICE WHILE THE PATIENT WAS IN THE ROOM WHICH CAUSED A DELAY FOR AN UNKNOWN AMOUNT OF TIME. THE BRONCHOSCOPY WAS COMPLETED WITHOUT THE USE OF THE VERAN SPIN THORACIC NAVIGATION SYSTEM. THE PATIENT WAS ALSO REFERRED TO ANOTHER HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715874 ↗
• MalfunctionSep 8, 2023Complete Loss of Power; Complete Loss of Power

  THE CUSTOMER REPORTED TO OLYMPUS THE VERAN SPIN THORACIC NAVIGATION SYSTEM® (USA) WAS POWERED ON PRIOR TO THE START OF A PROCEDURE WHEN THE USER NOTED THE SCREENS WERE NOT RECEIVING INPUT. AFTER TROUBLESHOOTING, IT WAS DETERMINED THE CPU WAS NOT RECEIVING POWER. AS A RESULT, THE VERAN NAVIGATION PORTION OF THE PROCEDURE HAD TO BE CANCELLED, BUT THE REST OF THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT AS A RESULT OF THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715818 ↗
• InjuryAug 17, 2023Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE SPIN THORACIC NAVIGATION SYSTEM WAS BEING USED DURING A DYE MARKING LOCALIZATION PROCEDURE PRIOR TO A LAPAROSCOPIC BIOPSY WHEN THE IMAGE AND INSTRUMENT WERE BEING SHOWN ON SCREEN TO MOVE ERRATICALLY DESPITE THE DEVICE REMAINING STATIONARY. ANOTHER ALWAYS-ON TIP TRACKED NEEDLE WAS USED BUT DISPLAYED THE SAME PROBLEM DURING DEVICE REGISTRATION. BECAUSE THE NAVIGATION COULD NOT BE USED, THE PROCEDURE WAS CANCELLED AFTER 30 MINUTES OF THE PATIENT BEING UNDER ANESTHESIA WITH PLANS TO COMPLETE THE BIOPSY VIA A CONE-BEAM CT AND A LAPAROTOMY PROCEDURE. DESPITE THE PROCEDURAL DELAY AND CHANGED PLAN, THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568418 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JOURNAL ARTICLE: DIAGNOSTIC YIELD AND SAFETY OF BIOPSY GUIDED BY ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR HIGH-RISK PULMONARY NODULES. PUBLICATION DATE: FEBRUARY 24, 2021. BACKGROUND: ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) IS A USEFUL METHOD TO OBTAIN TISSUE FOR PERIPHERAL LUNG NODULES. WE AIMED TO UNDERSTAND THE DIAGNOSTIC YIELD AND SAFETY PROFILE IN HIGH-RISK PULMONARY NODULES THAT CANNOT BE ACCESSED BY PERCUTANEOUS TRANSTHORACIC NEEDLE BIOPSY. BASED ON THE ARTICLE, THERE WERE SEVEN (7) ADVERSE EVENTS DOCUMENTED: -THERE WERE FOUR (4) PATIENTS THAT EXHIBITED MODERATE BLEEDING THAT REQUIRED COLD SALINE AND TOPICAL EPINEPHRINE. ONE (1) OF THE FOUR (1) PATIENTS EXPERIENCED RESPIRATORY FAILURE THAT REQUIRED INTUBATION DUE TO OBSTRUCTION OF THE BRONCHUS BY A BLOOD CLOT. -THERE WERE THREE (3) PATIENTS THAT DEVELOPED A PNEUMOTHORAX. ONE (1) OF THE THREE (3) PATIENTS REQUIRED A CHEST TUBE INSERTION. THERE WAS NO ALLEGATION OR INFORMATION TO SUGGEST THERE WAS AN ASSOCIATED MALFUNCTION OF A VERAN DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax; Respiratory Failure

  MAUDE report 17279610 ↗
• MalfunctionJun 30, 2023Device Emits Odor; Device Emits Odor

  THE FACILITY REPORTED THAT AFTER THE PROCEDURE WAS COMPLETED, THE STAFF NOTICED THAT THE SYSTEM SMELLED OF SMOKE. A VERAN REPRESENTATIVE WENT ON-SITE ON (B)(6) 2021, TO TROUBLESHOOT AND FOUND THAT THE SMELL WAS COMING FROM THE CENTRAL PROCESSING UNIT (CPU) IN THE SYSTEM. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242497 ↗
• InjuryJun 30, 2023No Display/Image; No Display/Image

  THE SYS-4000 WAS PLUGGED INTO A WALL OUTLET WHEN THE TOWER WAS ROLLED INTO THE OPERATING ROOM FOR SET UP. THE SITE STARTED THE PROCEDURE WITH AN OLYMPUS BF-P190 SCOPE AND REGISTERED WITH FORCEPS. AFTER NAVIGATING OUT TO THE TARGET AND TRYING TO SAMPLE UNSUCCESSFULLY, THEY SWITCHED TO A SPIN VISION 4.0 SCOPE 2.0 WORKING CHANNEL. WHEN THE SCOPE WAS PLUGGED IN, IT WAS JUST DISPLAYING A BLACK IMAGE (NO PICTURE WAS BEING SHOWN). THEY OPENED ANOTHER SPIN VISION SCOPE AND THE ISSUE PERSISTED. THEY WERE NOT ABLE TO GET THE SYSTEM 4000 TO WORK AGAIN AND TRIED TO SAMPLE BLINDLY BEFORE MOVING ON WITH THE CASE. THE VERAN NAVIGATED PORTION OF THE PROCEDURE WAS DISCONTINUED. THE PHYSICIAN PERFORMED A BRONCHEOALVEOLAR LAVAGE (BAL). THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER A 30-MINUTE DELAY. ALTHOUGH THERE WAS NO IMPACT ON THE PATIENT, THIS EVENT IS BEING REPORTED DUE TO THE 30-MINUTE DELAY WHILE THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242481 ↗
• InjuryJun 30, 2023Connection Problem; Connection Problem

  THE SITE RECENTLY REPLACED THEIR CONNECTOR CABLE PORT DUE TO IT BEING BROKEN. DURING THEIR CASE THEY CONTINUED TO RECEIVE A "VPAD NOT CONNECTED" ERROR MESSAGE. THEY TRIED SEVERAL DIFFERENT CONNECTOR CABLES AND WERE STILL RECEIVING THIS ERROR MESSAGE. THEY DECIDED NOT TO PROCEED WITH VERAN. ALTHOUGH THERE WAS NO DEATH OR SERIOUS INJURY, THIS EVENT IS BEING REPORTED DUE TO THE NAVIGATED PROCEDURE BEING DISCONTINUED AFTER THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242473 ↗
• InjuryJun 30, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PHYSICIAN REPORTED THAT THE SCREEN WAS SHAKING WHEN NAVIGATING. THE COMPUTED TOMOGRAPHY (CT) AND VIRTUAL VIEWS HAD THE CROSS-HAIRS JUMPING AROUND EVEN WHEN THE INSTRUMENT WAS HELD STEADY AND NOT MOVING. THE NAVIGATED PROCEDURE WAS ABORTED. THIS REPORT IS BEING SUBMITTED FOR THE ABORTED NAVIGATION PROCEDURE WHILE THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242466 ↗
• MalfunctionMar 15, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE SET-UP IN THE ENDOSCOPY SUITE, AFTER THE DOCTOR PLUGGED AN INS-7130 (SPIN VISION SINGLE-USE FLEXIBLE BRONCHOSCOPE) INTO THE SYS-5100 (SPIN VISION PROCESSOR), WHICH IS A COMPONENT OF THE SYS-4000 (SPIN THORACIC NAVIGATION SYSTEM), THE IMAGE WAS SHOWING STATIC/SPARKLING ON THE SCREEN. WHITE BALANCING AND CFS WERE PRESSED A FEW TIMES TO TRY AND CORRECT THE ISSUE. THE BRONCHOSCOPE WAS UNPLUGGED AND RE-PLUGGED WITHOUT SUCCESS TO CORRECT THE IMAGE ISSUE. THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE, HOWEVER THE INTENDED NAVIGATED PROCEDURE WAS REPORTEDLY COMPLETED. THERE WAS NO IMPACT ON THE PATIENT DUE TO THE DELAY OR THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549615 ↗
• InjuryFeb 3, 2023Computer Software Problem; Insufficient Device Problem Information; Computer Software Problem; Insufficient Device Problem Information

  WITH A PATIENT UNDER ANESTHESIA, THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294622 ↗
• InjuryFeb 11, 2022Break

  THE PORT USED TO LINK THE VPADS TO THE SYSTEM WAS DAMAGED BY ANOTHER HOSPITAL EMPLOYEE BEFORE THE CASE STARTED BUT AFTER THE PATIENT WAS UNDER ANESTHESIA ON THE TABLE. THE DAMAGE COULD NOT BE FIXED SO THE CASE WAS ABORTED. NOTE: THIS REPORT WAS ORIGINALLY SUBMITTED ON JANUARY 12, 2022. IT WAS REJECTED DUE TO A DUPLICATE NUMBER USED IN THE REPORT SECTION. NO ADDITIONAL INFORMATION HAS CHANGED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13516108 ↗
• MalfunctionJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOSPITAL STAFF CALLED TECHNICAL SUPPORT AT VERAN AFTER THE PATIENT WAS INTUBATED TO TROUBLESHOOT THE SYSTEM BEEPING AND SCREENS NOT TURNING ON. RECOMMENDED PROTOCOL FOR USE OF SYSTEM IS TO CONFIRM THE SYSTEM IS WORKING BEFORE PATIENT IS INTUBATED. THE STAFF HAD ALSO ALREADY OPENED THE SIDES OF THE SYSTEM BEFORE CALLING TECHNICAL SUPPORT. AFTER SEVERAL TROUBLESHOOTING STEPS WHERE ATTEMPTED WITH TECHNICAL SUPPORT, IT BECAME APPARENT THAT THE CPU ON THE TOWER WAS NOT RECEIVING POWER CAUSING OTHER HARDWARE ELEMENTS TO BEEP FROM A LACK OF POWER EVEN AFTER THE SITE'S STAFF ATTEMPTED TO SECURE ALL PLUGS INSIDE THE SYSTEM. NOTHING FURTHER COULD BE DONE TO FIX THE TOWER AT THE TIME. PHYSICIAN WAS ONLY PLANNING ON DOING A VERAN PROCEDURE SO HE DID NOT COMPLETE THE PROCEDURE. PROCEDURE WAS RESCHEDULED, CPU WAS REPLACED, AND PROCEDURE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 11148828 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS A (B)(6) MALE WITH NO KNOWN PRE-EXISTING CONDITIONS. AT THE TIME OF THE INCIDENT, NO INSTRUMENTS OF VERAN WERE BEING USED. PRIOR TO INCIDENT, PHYSICIAN HAD MADE ROUGHLY 3 PASSES TO GET TO THE RUL NODULE. DUE TO PATIENT MOVEMENT AND COUGHING, PHYSICIAN TOOK OUT THE FORCEPS FROM SCOPE AND TRIED TO WAIT FOR PATIENT TO RELAX. A FEW MINUTES LATER, THE PATIENT STOPPED BREATHING, THE MEDICAL TEAM ATTENDED TO THE PATIENT, AND THE CASE WAS ABORTED. THE PATIENT STAYED OVERNIGHT AND NO ISSUES WERE SEEN AFTER BEING ADMITTED TO THE HOSPITAL FOR MONITORING.

  Patient problems: Apnea

  MAUDE report 10697857 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PNEUMOTHORAX AND CHEST TUBE WAS PLACED AFTER THE CASE.

  Patient problems: Pneumothorax

  MAUDE report 10330361 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CASE ON (B)(6) 2020 THE PHYSICIAN DECLINED VERAN REPRESENTITIVE'S OFFERING OF THE TRIPLE NEEDLE BRUSH CITING THAT HE HAD USED THE PRODUCT IN A PREVIOUS CASE WHERE THE PATIENT RESULTED IN A PNEUMOTHORAX. VERAN REPRESENTITIVE REPORTED INCIDENT TO VSUPPORT 03-JUNE-2020, AND ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN. VERAN REPRESENTITIVE CONTACTED PHYSICIAN THREE TIMES AND RECEIVED A RESPONSE 17-JUNE-2020. PHYSICIAN RESPONDED, "THAT'S ONLY ONE TIME SO I DON'T RESTRICT MYSELF TO USE FOR THE FUTURE. EMPHYSEMA PTS DO HAVE RISK OF PNEUMOTHORAX SO I'LL GIVE FUTURE CHANCE TO TRIPLE BRUSH. PT DID VERY WELL AFTER CHEST TUBE PLACEMENT." FOLLOW-UP REPORTED ON 18-JUN-2020 - CASE WAS HELD (B)(6) 2020 - PATIENT HAD CT GUIDED BIOPSY COMPLETED AT DEACONESS MIDTOWN. A PNEUMOTHORAX OCCURED AND A CHEST TUBE WAS ADMINISTERED. PATIENT WAS STABILIZED. VERAN REPRESENTATIVE MET WITH A MEMBER OF THE RESPIRATORY THERAPIST TEAM WHO SHOWED THE REPRESENTATIVE THE PATIENTS FILE. THE CT GUIDED PNEUMOTHORAX AND CHEST TUBE PLACEMENT WAS DOCUMENTED.

  Patient problems: Pneumothorax

  MAUDE report 10228672 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON COMPLETION OF THE PROCEDURE WHICH INCLUDED LINEAR EBUS, VERAN ENB AND CONVENTIONAL TBNA, THE PATIENT PRESENTED WITH A PNEUMOTHORAX OF THE RIGHT LUNG. THE PHYSICIAN PLACED A CHEST TUBE.

  Patient problems: Pneumothorax

  MAUDE report 10159901 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INSERTED THE SCOPE TO DO AN AIRWAY INSPECTION BEFORE BEGINNING REGISTRATION. DURING THIS TIME, THE PHYSICIAN NOTICED THAT THERE WAS SOME BLOOD IN THE TRACHEA FROM INTUBATION. THE PHYSICIAN PROCEEDED WITH THE AIRWAY INSPECTION AND EXPERIENCED SOME SLIGHT BLEEDING. THE PHYSICIAN AND VERAN REPRESENTATIVE WENT THROUGH REGISTRATION WITH NO PROBLEMS. THE PHYSICIAN NAVIGATED OUT TO THE TARGET AND TOOK ONE BITE WITH THE SERRATED FORCEPS. IMMEDIATELY AFTER THE BITE, THE PATIENT'S STATS DROPPED AND THEY BEGAN BLEEDING HEAVILY. THE VERAN REPRESENTATIVE STEPPED OUT OF THE ROOM WHILE ANESTHESIA AND THE PHYSICIAN WORKED TO STABILIZE THE PATIENT. AFTER A FEW MINUTES, THE PATIENT BECAME STABLE AGAIN AND THE PHYSICIAN ABORTED THE REST OF THE CASE. VERAN REPRESENTATIVE SPOKE WITH THE PHYSICIAN ON (B)(6) 2020 WHEN THE REPRESENTATIVE WAS NOTIFIED THAT THE PATIENT HAD TO BE ADMITTED TO THE HOSPITAL AFTER THE CASE.

  Patient problems: Blood Loss

  MAUDE report 10092182 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN PLANNED THE PROCEDURE WITHOUT ISSUE. THE ADVERSE EVENT TOOK PLACE DURING THE NAVIGATION PORTION OF THE PROCEDURE. THE PHYSICIAN PERFORMED A MANUAL REGISTRATION USING THE SERRATED FORCEPS. AFTER COLLECTING LUMEN POINTS, THE LOCATIONS OF BOTH THE MAIN AND SECONDARY CARINAS WERE VERIFIED AND ACCURATE. THE PHYSICIAN THEN PROCEEDED TO THE NAVIGATION PORTION OF THE PROCEDURE. HE WAS AFTER A LARGE 3-4CM MASS IN THE RIGHT UPPER LOBE. INITIALLY, THE PHYSICIAN BEGAN SAMPLING WITH THE 22GA NEEDLE. HE TOOK 3-4 SAMPLES ON THE INFERIOR AND LATERAL BORDER OF THE NODULE. THE PHYSICIAN NOTED THAT THE NEEDLE WAS "SLIPPING" WHEN HE WENT TO DEPLOY IN THE DESIRED LOCATION. THUS, HE SWITCHED TO A MORE RIGID 19GA NEEDLE. AFTER NAVIGATING TO THE DESIRED LOCATION, HE TOOK A SAMPLE FROM THE AREA OF INTEREST IN WHAT APPEARED TO BE THE CENTER OF THE NODULE. AS THE NURSE IN THE ROOM WAS EXTRACTING THE SAMPLE FROM THE NEEDLE, THE PHYSICIAN NOTED THE PATIENT STARTED TO BLEED PROFUSELY AND LACKED A TIDAL SIGN DURING RESPIRATION. HE ADMINISTERED COLD SALINE/LIDOCAINE IN AN ATTEMPT TO CONTROL THE BLEEDING-BOTH METHODS WERE UNSUCCESSFUL. AT THIS POINT, THE PHYSICIAN CALLED THE ANESTHESIOLOGIST AS WELL

  Patient problems: Blood Loss

  MAUDE report 10092181 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLANNED FOR A RLL SEGMENTED 22MM TARGET WITH 8.3MM OF MOTION IN WHAT PHYSICIAN SAID WAS THE SUPERIOR BASAL SEGMENT OF A (B)(6) Y/O MALE. DURING REGISTRATION WITH A 21GA NEEDLE, THE MAIN CARINA WAS ADJUSTED WITH "TOUCH MAIN CARINA". THE SECONDARY WAS CONSIDERED ACCURATE AS THE INSTRUMENT'S CROSSHAIR WAS IN THE CENTER OF THE BLUE BULLSEYE IN THE CT VIEWS. HE CONTINUED NAVIGATING WITH THE NEEDLE AND FOUND A BIT OF A DIFFICULT TRAJECTORY. HE TOOK TWO SAMPLES AND WAS GOING TO SWITCH TO FORCEPS. AFTER ABOUT 4 MINUTES OF DOWNTIME SWITCHING INSTRUMENTS TO THE FORCEPS AND MOVING MONITORS, THE RN, SAID THEY WERE GOING TO WAIT FOR THE PATIENT'S HEART RATE TO SLOW BACK DOWN. AFTER A COUPLE OF MINUTES, SHE ASKED IF THE VPADS WOULD INHIBIT EKG LEADS. THEY TOOK AN EKG AND MADE THE DECISION TO SEND THE PATIENT TO THE CATH LAB. WHEN ASKED ABOUT BLEEDING VERSE HEART ISSUES. SHE SAID, "NO, NO BLEEDING. EVERYTHING IS OKAY WE'RE JUST SENDING THEM TO THE CATH LAB." CASE WAS ENDED.

  Patient problems: Tachycardia

  MAUDE report 10092176 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED. DOCTOR QUICKLY ACCESSED THE NODULE AND TOOK 6 CORE BIOPSIES/2 FNAS. THE PATIENT PRESENTED WITH A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED.

  Patient problems: Pneumothorax

  MAUDE report 9401573 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. BEGAN WITH EBUS AND THEN SWITCHED TO NAVIGATION. TOOK A COUPLE OF PASSES WITH 22GA NEEDLE, BUT BOTH RETURNED BLOODY SLIDES. CASE ABORTED SHORTLY AFTERWARDS BECAUSE OF EXCESSIVE BLEEDING. INSUFFICIENT INFORMATION REGARDING TREATMENT FOR BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9401572 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED BLEEDING, CLOTTING AND HAS BEEN VENTILATED SEVERAL TIMES DURING LEBUS. NAVIGATION OPERATED AS INTENDED, HOWEVER, DOCTOR WAS ONLY ABLE TO OBTAIN ONE SAMPLE BEFORE THE CASE ENDED ABRUPTLY AND THE PATIENT WAS ADMITTED DUE TO EXCESSIVE BLEEDING. GRADE 3-4 BLEEDING INDICATED.

  Patient problems: Blood Loss

  MAUDE report 9401568 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. DOCTOR BEGAN WITH EBUS BEFORE SWITCHING OVER TO NAVIGATION. WAS ABLE TO COLLECT A FEW BIOPSIES USING THE FORCEPS BEFORE HAVING TO ABORT THE PROCEDURE AS A RESULT OF EXCESSIVE BLEEDING. INSUFFICIENT INFORMATION TO DETERMINE TREATMENT FOR BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9401561 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. DOCTOR WAS ABLE TO GRAB MULTIPLE SAMPLES. TOUGH LOCATION BUT WAS PLEASED WITH THE RESULTS. PATIENT DID RECEIVE A PNEUMOTHORAX DUE TO RT PUNCTURING LUNG WITH NEEDLE.

  Patient problems: Pneumothorax

  MAUDE report 9401559 ↗