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superDimension AAS00161-20 (UDI 10884521199989)Recalls & reported problems

Covidien LP · Navigation System · Class 2

All models of superDimension (20)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Covidien superDimension navigation system guides a bronchoscope to lung spots for biopsy. Some reports summarize published studies of navigation bronchoscopy, which mention complications such as collapsed lung (pneumothorax). Other reports describe the screen going dark mid-procedure and cable problems. There are 127 injury reports and 44 death reports. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
190
Deaths reported
44
Injuries reported
127
Recalls naming it
0

Summary

The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 10884521199989), received between Sep 23, 2016 and Sep 3, 2025 — classified as 44 deaths, 127 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (34 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 3 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem103
  • Application Program Problem34
  • Patient Data Problem24
  • Device Displays Incorrect Message22
  • Application Network Problem9
  • Programming Issue8
  • Connection Problem7
  • Defective Device5

Patient problems

  • Pneumothorax53
  • Death44
  • No Code Available31
  • No Known Impact Or Consequence To Patient22
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available20
  • Blood Loss8
  • No Clinical Signs, Symptoms or Conditions8
  • No Consequences Or Impact To Patient6

Recent adverse event reports

The 25 most recent of 190 reports, in the reporter's own words as published by the FDA.

  • InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO A RETROSPECTIVE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN FEBRUARY 2016 AND DECEMBER 2019 TO COMPARE THE RESULTS OF 100 PATIENTS WHO UNDERWENT THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY-TRANSBRONCHIAL LUNG BIOPSIES (TBLBS) WITH THOSE OF 50 VIR TUAL BRONCHOSCOPY NAVIGATION (VBN)-TBLBS AT A SINGLE INSTITUTION. THE FIRST 35 PATIENTS UNDERWENT ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) WITHOUT FLUOROSCOPY GUIDANCE TWO OF WHOM (5.7%) REQUIRED THORACIC DRAINAGE FOR PNEUMOTHORAX. FLUOROSCOPIC GUIDANCE FOR TARGETS NEAR THE PLEURAL SURFACE WERE USED TO THE REMAINING 65 PATIENTS TO MINIMIZE RISK. ONLY TWO OF WHOM (3.1%) HAD PNEUMOTHORAX.

    Patient problems: Pneumothorax

    MAUDE report 22952380 ↗
  • MalfunctionSep 3, 2025Patient Data Problem; Patient Data Problem

    ACCORDING TO A RETROSPECTIVE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN FEBRUARY 2016 AND DECEMBER 2019 TO COMPARE THE RESULTS OF 100 PATIENTS WHO UNDERWENT THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY-TRANSBRONCHIAL LUNG BIOPSIES (TBLBS) WITH THOSE OF 50 VIR TUAL BRONCHOSCOPY NAVIGATION (VBN)-TBLBS AT A SINGLE INSTITUTION. COMPLICATIONS INCLUDED INCOMPLETE REGISTRATION IN TWO PATIENTS (2%).

    Patient problems: Insufficient Information

    MAUDE report 22952336 ↗
  • InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN AUGUST 2014 AND JANUARY 2020, A RETROSPECTIVE STUDY EVALUATED THE DIAGNOSTIC YIELD OF ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY IN PATIENTS. THERE WERE 81 PROCEDURES PERFORMED ON 77 PATIENTS. ALL PROCEDURES WERE PERFORMED WITH THE SUPER-DIMENSION SYSTEM. GENCUT AND OTHER TOOLS WERE USED FOR DIAGNOSIS. POSTOPERATIVE COMPLICATIONS INCLUDED PNEUMOTHORAX AND MINOR BLEEDING FOR 2 CASES. CHEST TUBE PLACEMENT AND HOSPITALIZATION OCCURRED IN ONE PATIENT WITH PNEUMOTHORAX.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

    MAUDE report 22951569 ↗
  • InjuryMar 13, 2025Poor Quality Image; Failure to Power Up; Application Program Problem; Poor Quality Image; Failure to Power Up; Application Program Problem

    ACCORDING TO THE REPORTER, DURING THE ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE PROCEDURE WAS NOT COMPLETED AS THE SYSTEMS SCREEN WENT BLACK DURING THE PROCEDURE AND THE PHYSICIAN COULD NOT GET IT BACK ON. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE SUPER DIMENSION PORTION OF THE CASE. AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) WAS DONE TO COMPLETE THE PROCEDURE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21594629 ↗
  • InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE LEARNING CURVE OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) IN PATIENTS WITH SMALL PERIPHERAL PULMONARY NODULES BETWEEN NOVEMBER 2019 AND DECEMBER 2021. SUPERDIMENSION WAS USED TO RECONSTRUCT THE VIRTUAL BRONCHUS RECONSTRUCTION AND IDENTIFY THE PATHWAY TO THE TARGET LESION. COMPLICATIONS RELATED TO THE ENB PROCEDURE INCLUDED PNEUMOTHORAX IN TWO PATIENTS. INTERVENTIONS WERE NOT REPORTED.

    Patient problems: Pneumothorax

    MAUDE report 21124944 ↗
  • InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN AUGUST 2021 AND JUNE 2023, THE RESULTS OF THE VERITAS TRIAL, NAVIGATIONAL BRONCHOSCOPY (NB) WAS COMPARED TO COMPUTED TOMOGRAPHY-GUIDED TRANSTHORACIC NEEDLE BIOPSY. A TOTAL OF 234 PATIENTS WITH PERIPHERAL LUNG NODULES UNDERWENT BIOPSY PROCEDURES. NB WAS PERFORMED IN 121 PATIENTS. PER THE STUDY PROTOCOL, SUPERDIMENSION ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY PLATFORM WITH DIGITAL TOMOSYNTHESIS CAPABILITY WAS USED FOR ALL NB PROCEDURES. COMPLICATIONS IN THE NB GROUP INCLUDED PNEUMOTHORAX IN 4 PATIENTS. ONE PATIENT REQUIRED TUBE THORACOSTOMY.

    Patient problems: Pneumothorax

    MAUDE report 20673892 ↗
  • MalfunctionOct 29, 2024Device Displays Incorrect Message; Communication or Transmission Problem; Device Displays Incorrect Message; Communication or Transmission Problem

    ACCORDING TO THE REPORTER, DURING A ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THERE WAS AN ISSUE WITH THE LOCATION BOARD SIGNAL CUTTING IN AND OUT OF SENSING VOLUME. AFTER GETTING TECHNICAL SERVICES ON THE LINE, IT WAS DETERMINED THAT THERE WAS MOST LIKELY AN ISSUE WITH ONE OF THE CORD CONNECTIONS. THE STAFF THEN TRIED A SECOND SPARE LONG LOCATION BOARD CABLE TO SEE IF THIS WOULD RESOLVE THE ISSUE, IT DID NOT. THEY WERE ABLE TO SUCCESSFULLY FINISH THE CASE THAT THEY HAD ALREADY STARTED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20558596 ↗
  • MalfunctionJun 4, 2024Unintended Application Program Shut Down; Unintended Application Program Shut Down

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SYSTEM WOULD GO DARK IN THE MIDDLE OF THE CASE, AND WE WOULD NEED TO RESTART THE SYSTEM AND RE-REGISTER THE PATIENT. ALL POWER OUTLETS AND CABLES WERE CHECKED AND WERE SECURE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19461918 ↗
  • MalfunctionApr 17, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN OUT OF SENSING VOLUME.

    Patient problems: Insufficient Information

    MAUDE report 19126048 ↗
  • MalfunctionMar 8, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS A LOCATION GUIDE (LG) OUT OF SENSING VOLUME ERROR. A NUMBER OF TROUBLESHOOTING STEPS WITH TECHNICAL SUPPORT ON THE PHONE WAS DISCUSSED,  BUT, UNABLE TO MOVE PAST THIS ERROR. THE CUSTOMER TRIED PLACING A PILLOW UNDER THE PATIENT AND STILL DID NOT WORK. THE PHYSICIAN MOVE FORWARD WITH THE CASE BY PERFORMING ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS). THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18869109 ↗
  • InjuryOct 24, 2023Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CUSTOMER CALLED IN WITH THE PATIENT ON THE TABLE FIRST TO TROUBLESHOOT PATIENT SENSOR TRIPLET (PST) PLACEMENT ERROR, THEN THE LOCATABLE GUIDE (LG) OUT OF SENSING VOLUME ERROR. THE CUSTOMER REPLACED THE LOCATION BOARD (LB) CONNECTING CABLE AND LG CABLE. THE CASE WAS NOT COMPLETED AND NOT COMPLETED BY ANOTHER MEANS. THE PATIENT WAS UNDER ANESTHESIA. IT WAS NOTED THE PROCEDURE WAS NOT RESCHEDULED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17997845 ↗
  • InjuryOct 20, 2023Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOCATION BOARD WAS DISCONNECTED. THE SURGEON HAD TO RESTART THE PROCEDURE. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. HOWEVER, THE PATIENT HAD PNEUMOTHORAX, WHICH REQUIRED A CHEST TUBE. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AS WELL.

    Patient problems: Pneumothorax

    MAUDE report 17981443 ↗
  • InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD PNEUMOTHORAX. IT WAS NOTED THAT BIOPSIES WAS ABLE TO BE TAKEN. TO RESOLVE THE ISSUE, CHEST TUBE WAS USED.

    Patient problems: Pneumothorax

    MAUDE report 17671084 ↗
  • MalfunctionJun 30, 2023Computer Software Problem; Device Displays Incorrect Message; Computer Software Problem; Device Displays Incorrect Message

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS AN OUT OF SENSING VOLUME WHEN NAVIGATED TO THE TARGET, SAMPLED AND RE-INSERTED THE CATHETER. THE SOFTWARE REBOOTED ITSELF. ADVISED THE DEFRAG THE SYSTEM DURING THE UPCOMING PREVENTATIVE MAINTENANCE AND TO EXPORT THE PROCEDURE RECORDING. THE PATIENT WAS UNDER ANESTHESIA. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17242193 ↗
  • InjuryJun 5, 2023Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SYSTEM FROZE TWICE. THE CASE WAS NOT COMPLETED EVEN BY OTHER MEANS. IT WAS NOTED THAT THE PATIENT WAS UNDER ANESTHESIA.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 17061117 ↗
  • InjuryMay 12, 2023Defective Device; Defective Device

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY AND FEASIBILITY OF IMAGE-GUIDED TRANSBRONCHIAL MICROWAVE ABLATION FOR PATIENTS WITH PERIPHERAL STAGE 1 LUNG CANCER. THE ABLATION PROCEDURE WAS PERFORMED USING NAVIGATIONAL BRONCHOSCOPY AND A FLEXIBLE MICROWAVE ABLATION PROBE WHICH WAS GUIDED BY COMPUTED TOMOGRAPHY AND FLUOROSCOPY. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY WAS PERFORMED WITH SUPERDIMENSION 7.1. EDGE WAS USED WITHOUT NAVIGATION IN TWO PATIENTS WHERE THERE WERE TECHNICAL DIFFICULTIES WITH SUPERDIMENSION. THERE WERE TEN PATIENTS IN THE STUDY AND MILD COMPLICATIONS INCLUDED: SCANT HEMOPTYSIS, CHEST WALL PAIN, COUGH, AND DYSPNEA. ONE PATIENT EXPERIENCED HEMORRHAGE WHICH WAS TREATED INTRAOPERATIVELY WITH COLD SALINE AND BRONCHOSCOPIC TAMPONADE. ONE PATIENT ALSO HAD LENGTHY BRONCHOSCOPIC NAVIGATION WITH LOCAL BLEEDING.

    Patient problems: Chest Pain; Dyspnea; Hemoptysis; Hemorrhage/Blood Loss/Bleeding

    MAUDE report 16924225 ↗
  • InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    ACCORDING TO LITERATURE SOURCE OF COHORT STUDY, IN THE FIRST SIX MONTHS, THE AUTHORS COMPARED THE DIAGNOSTIC YIELD OF TWO PLATFORMS, DIGITAL TOMOSYNTHESIS-ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (DT-ENB, SUPERDIMENSION;) AND SHAPE-SENSING ROBOTIC-ASSISTED BRONCHOSCOPY (SSRAB). SSRAB WAS USED TO BIOPSY 143 PPLS IN 133 PATIENTS AND DT-ENB WAS USED TO BIOPSY 197 PPLS IN 170 PATIENTS. TRANSBRONCHIAL NEEDLE ASPIRATION WAS THE Q9 INITIAL BIOPSY METHOD IN ALL PATIENTS USING THE 21-GAUGE PULMONARY NEEDLE IN DT-ENB PROCEDURES AND 19-GAUGE, 21-GAUGE, OR 23-GAUGE NEEDLES FROM ANOTHER MANUFACTURER IN SSRAB PROCEDURES. POST OPERATIVE COMPLICATIONS WAS PNEUMOTHORAX ON TWO (2) PATIENTS  (1.5%) OF SSRAB AND ON THREE PATIENTS (1.8%) OF DT-ENB. ONE PATIENT (0.6%) IN THE DTENB GROUP AND 2 PATIENTS (1.5%) IN THE SSRAB GROUP REQUIRED TUBE THORACOSTOMY. NO PATIENTS REQUIRED ADDITIONAL INTERVENTION BECAUSE OF BLEEDING IN EITHER COHORT. THE SURGEON CONFIRMED THAT COMPLICATIONS IN THIS STUDY WE¿RE NOT RELATED TO THE DEVICES.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pneumothorax

    MAUDE report 16744104 ↗
  • InjuryFeb 3, 2023Application Program Problem; Patient Data Problem; Application Program Problem; Patient Data Problem

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THERE WAS ISSUE WITH REGISTRATION. THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WAS NOT COMPLETED AND CASE WAS NOT COMPLETED BY OTHER MEANS.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16293966 ↗
  • InjuryDec 19, 2022Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SYSTEM FROZE MID PROCEDURE AND CASE WAS CANCELLED. PATIENT WAS UNDER ANESTHESIA. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE CASE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16005569 ↗
  • InjuryMay 11, 2022Patient Data Problem; Patient Data Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A REGISTRATION ISSUE. THE PROCEDURE WAS ABORTED. ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) WAS ATTEMPTED, BUT THE PATIENT DID NOT HAVE LYMPH NODES THAT WERE SAFE TO BIOPSY, DUE TO SMALL SIZE. THE PATIENT WAS UNDER ANESTHESIA.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 14366675 ↗
  • InjuryMar 28, 2022Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem

    ACCORDING TO THE REPORTER DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO REGISTER BUT THEN WAS GIVEN A NOTICE THAT THERE WAS AN OUT OF SENSING VOLUME WHILE IN THE UPPER LEFT LOBE. THE NURSE INDICATE PATIENT WAS A BIT SMALLER THAN AVERAGE. OVER THE PHONE, TECHNICAL SERVICE (TS) AND NURSE TESTED THE PATIENT SENSOR TRIPLET (PST)S AND ENSURED ALL AREAS SEEMED TO READ THE PSTS. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE CASE. PATIENT WAS UNDER ANESTHESIA. THEY PLAN TO BRING THE PATIENT BACK FOR AN ADDITIONAL FUTURE PROCEDURE TO REATTEMPT WITH THE SYSTEM.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13930425 ↗
  • InjuryMar 2, 2022Device Displays Incorrect Message; Application Program Problem; Device Displays Incorrect Message; Application Program Problem

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CUSTOMER WAS RECEIVING MESSAGE THAT SENSOR WAS OUTSIDE OF THE SENSING VOLUME WHILE REGISTRATION WAS BEING CONDUCTED. THE PROCEDURE WAS NOT COMPLETED AND WAS NOT COMPLETED BY OTHER MEANS AS WELL. PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WILL BE RESCHEDULED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13653427 ↗
  • InjuryDec 21, 2021Device Displays Incorrect Message; Application Program Problem; Connection Problem; Device Displays Incorrect Message; Application Program Problem; Connection Problem

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SYSTEM WAS SHOWING A "LOCATABLE SUB-SYSTEM (LSS) DISCONNECTED ERROR". TRIED TO RESTART THE SYSTEM A COUPLE OF TIMES BUT WITH NO LUCK. VERIFIED THE INTERNET PROTOCOL (IP) ADDRESS ON THE TRACKER AND IT WAS CORRECT, POWER WAS ON ALL COMPONENTS, REMOVED AND RE PLUGGED THE ORANGE ETHERNET CABLE, AND VERIFIED THAT THE LSS FILES WERE ALL THERE AND THERE WERE NO ISSUES FOUND IN THE DEVICE MANAGER. ATTEMPTED A DIFFERENT ETHERNET CABLE AND NO FIX. THE PROCEDURE WAS NOT COMPLETED AND WAS NOT COMPLETED BY OTHER MEANS. THE PATIENT WAS UNDER ANESTHESIA.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13052982 ↗
  • InjuryNov 7, 2021Application Program Problem; Patient Data Problem; Application Program Problem; Patient Data Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN ¿DONE¿ WAS PRESSED FOLLOWING REGISTRATION, THE SYSTEM WOULD NOT ALLOW TO COMPLETE THE REGISTRATION. CUSTOMER RE-STARTED THE REGISTRATION A FEW TIMES. ALSO, LOGGED OUT OF THE PROCEDURE APPLICATION AND STARTED OVER. THE PHYSICIAN WAS UNABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) PORTION OF THE CASE NOR COMPLETED THE CASE BY OTHER MEANS. THE PATIENT WAS RESCHEDULED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12763336 ↗
  • InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, THE APPLICABILITY OF ENB COMBINED RADIAL ENDOBRONCHIAL ULTRASOUND IN THE DIAGNOSIS OF LUNG NODULES WITH DIFFERENT DENSITIES WAS EXPLORED BETWEEN. PATIENTS WHO UNDERWENT BIOPSY FROM 2016-09 TO 2019-03 WERE DIVIDED INTO 2 GROUPS: THE SOLID NODULE GROUP AND THE SUBSOLID PULMONARY NODULE GROUP. A TOTAL OF 37 LESIONS IN 25 PATIENTS WERE BIOPSIED, 14 LESIONS WERE SUBSOLID PULMONARY NODULES AND 23 WERE SOLID NODULES. PNEUMOTHORAX OCCURRED IN 1 CASE (1/37, 2.7%). IN THIS PATIENT, THE LESION WAS ADJACENT TO THE PLEURA AND DIAPHRAGM, WHICH SUGGESTS A RELATIVE CONTRAINDICATION OF PTLB (PERCUTANEOUS LUNG BIOPSY). THE THORACIC PLEURA WAS PUNCTURED BECAUSE OF UNSATISFACTORY DEPTH CONTROL DURING THE BIOPSY. CLOSED THORACIC DRAINAGE WAS PERFORMED IMMEDIATELY. ONE DAY AFTER THE OPERATION, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Patient problems: Pneumothorax

    MAUDE report 12475844 ↗

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