Single Use Guide Sheath Kit K-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170245466), received between Jan 25, 2022 and Oct 15, 2024 — classified as 29 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 reports).

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. Jan 15, 2025Open, Classified

   Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

   Z-1071-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "SAFETY AND RISK FACTORS FOR BLEEDING COMPLICATIONS OF RADIAL PROBE ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL BIOPSY." THIS STUDY AIMED TO EVALUATE THE DIAGNOSTIC PERFORMANCE AND COMPLICATION RATE OF RADIAL EBUS-GUIDED TRANSBRONCHIAL BIOPSY (TBB) AND INVESTIGATE RISK FACTORS ASSOCIATED WITH PROCEDURE-RELATED BLEEDING EVENTS. OF (B)(4) PATIENTS (MEDIAN AGE, 69 YEARS; MEN (B)(4)) INCLUDED, (B)(4). THE MEDIAN PROCEDURE TIME WAS 22MIN (IQR, 15¿31MIN). THE DIAGNOSTIC ACCURACY, SENSITIVITY, AND SPECIFICITY FOR MALIGNANCY WERE (B)(4) RESPECTIVELY. WHEN THE (B)(4) PATIENTS WHO DID NOT UNDERGO TBB WERE INCLUDED, THE DIAGNOSTIC ACCURACY FOR MALIGNANCY WAS (B)(4). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: EVENT 1: BLEEDING (GRADE 2 OR HIGHER) (N=(B)(4)). OF (B)(4) WITH PROCEDURE-RELATED BLEEDING EVENTS, (B)(4) HAD DELPHI GRADE 2 BLEEDING EVENTS, AND ONLY (B)(4) HAD DELPHI GRADE 3 BLEEDING EVENTS. EPINEPHRINE WAS USED IN (B)(4) PATIENTS, AND A BALLOON BLOCKER WAS USED IN (B)(4) OF THEM FOR BLEEDING CONTROL. EVENT 2: PNEUMONIA (N=(B)(4)). NO TREATMENT INFORMATION WAS PROVIDED. EVENT 3: PNEUMOTHORAX (N=(B)(4)). (B)(4) PATIENTS REQUIRED PERCUTANEOUS CA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pleural Effusion; Pneumonia; Pneumothorax

  MAUDE report 20456703 ↗
• InjurySep 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC BRONCHIAL ULTRASOUND USING A GUIDE SHEATH, THE OPAQUE TIP OF THE SUBJECT DEVICE FELL INTO THE LUNGS AND WAS LEFT INSIDE THE BODY. THE TIP WAS ATTEMPTED TO BE REMOVED ENDOSCOPICALLY BUT IT COULD NOT BE COLLECTED. IT WAS NOTED THAT THERE WERE NO SHARP EDGES TO THE FALLEN PIECE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITHOUT ANY ISSUES NOTED. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20194278 ↗
• InjuryJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN INDUCTOR WAS NOT USED. HOWEVER, THE BIOPSY FORCEPS AND BRUSH INCLUDED IN THE SAME KIT WERE COMBINED WITH THE GUIDE SHEATH. ADDITIONALLY, THE BIOPSY FORCEPS FELT DIFFICULT TO PASS THROUGH. DESPITE THE POOR PASS ABILITY, IT WAS PUSHED AND PULLED AS IT WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704633 ↗
• InjuryJun 14, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN INDUCTOR WAS USED DURING THE PROCEDURE. THE GUIDE SHEATH WAS NOT INSERTED INTO A STRONG BENDING SITE OF THE BRONCHUS BUT WAS CONFIRMED TO BE INSERTED FROM THE LEFT B1+2 BRONCHUS (BRONCHOPULMONARY SEGMENT IN THE LEFT UPPER LOBE OF THE LUNG). MOREOVER, IT WAS REPORTED THAT WHEN USING THE GUIDE SHEATH FOR COMPRESSION HEMOSTASIS, THE ULTRASOUND PROBE OR PROCEDURE TOOL IS REMOVED WITH THE GUIDE SHEATH TIP STICKING OUT FROM THE TIP OF THE ENDOSCOPE.

  Patient problems: Foreign Body In Patient; Hemoptysis

  MAUDE report 19538600 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE SINGLE USE GUIDE SHEATH KIT WAS USED DURING GUIDED SHEATH PROCEDURE. THE PATIENT'S CONDITION "SUDDENLY CHANGED WHEN THE LUNGS WERE BEING LAVAGED AFTER THE BIOPSY." THE PATIENT "VOMITED A LOT OF BLOOD." ADDITIONAL INFORMATION OBTAINED THAT BLEEDING OCCURRED, CAUSING A 1-HOUR DELAY FOR HEMOSTASIS. THE PROCEDURE WAS THEN COMPLETED. THE HOSPITAL COMMENTED THAT THERE WAS NO PROBLEM WITH THE OLYMPUS PRODUCT AND THE BIOPSY ITSELF. FURTHER INFORMATION RECEIVED THAT CONFIRMED NO CHANGE TO OPEN SURGERY. PER THE CUSTOMER, THERE WAS A "POSSIBILITY THAT THE BLOOD WAS ASPIRATED BECAUSE IT TOOK SOME TIME TO ASPIRATE AFTER HEMOPTYSIS; THE BLEEDING WAS PROBABLY FROM THE BIOPSY SITE." THE PATIENT RECOVERED WELL AND APPEARED TO BE ABLE TO COMMUNICATE THE DAY AFTER THE PROCEDURE.

  Patient problems: Aspiration/Inhalation; Hematemesis; Hemoptysis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18956590 ↗
• InjuryFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A GUIDED SHEATH PROCEDURE THE SINGLE USE GUIDE SHEATH WAS ATTEMPTED TO BE PASSED THROUGH THE BRONCHOVIDEOSCOPE BUT DID NOT PROTRUDE FROM THE TIP OF THE SCOPE AS EXPECTED. THE TIP FELL OFF AND THE FALLEN PIECES WERE IMMEDIATELY RECOVERED USING GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18783132 ↗
• InjuryFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE METAL TIP OF THE SINGLE USE GUIDE SHEATH KIT WAS VISIBLE USING X-RAYS, BUT HALFWAY THROUGH, IT BECAME IMPOSSIBLE TO VISUALIZE IT AND HAD FALLEN OFF INSIDE THE PATIENT. THE BROKEN DEVICE WAS REMOVED AND CONFIRMED THAT THE MATERIAL COULD BE COLLECTED INTO A SUCTION BOTTLE USING A BRONCHOSCOPE. NO REPORT OF HEALTH DAMAGE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778988 ↗
• InjuryFeb 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A GUIDED SHEATH PROCEDURE THE GUIDE SHEATH WAS ATTEMPTED TO BE PASSED THROUGH THE SCOPE BUT DID NOT PROTRUDE FROM THE TIP OF THE SCOPE AS EXPECTED. THE TIP FELL OFF AND THE FALLEN PIECES WERE IMMEDIATELY RECOVERED USING GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764114 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF RADIAL ENDOBRONCHIAL ULTRASOUND FOR PERIPHERAL PULMONARY LESIONS WITHOUT AUTOMATION TECHNOLOGY IN TUBERCULOUS ENDEMIC REGION: REAL-WORLD EXPERIENCE IN A SINGLE INSTITUTION OVER 6 YEARS." THIS IS A RETROSPECTIVE CHART REVIEW OF ALL ADULT PATIENTS UNDERGOING RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS)-GUIDED TRANSBRONCHIAL BIOPSY FOR PERIPHERAL PULMONARY LESIONS (PPL) IN OUR INSTITUTION OVER 6 YEARS DURATION (OCTOBER 2016 TO DECEMBER 2022). VARIOUS FLEXIBLE CONVENTIONAL (BF-H190), THIN BRONCHOSCOPES (BF-MP190-F), RADIAL EBUS PROBES (K-201) AND AN ENDOBRONCHIAL BALLOON (B5-2C) WERE USED FOR THE PROCEDURES. DURING THE STUDY PERIOD, A TOTAL OF 558 PROCEDURES WERE PERFORMED. SEVEN CASES WERE EXCLUDED DUE TO THE PRESENCE OF VISIBLE ENDOBRONCHIAL LESIONS DURING INITIAL SCOUTING BRONCHOSCOPY. THE FINAL NUMBER OF PROCEDURES AVAILABLE FOR ANALYSIS WAS 551. PNEUMOTHORAXES: 1.1% - REQUIRING PERCUTANEOUS DRAINAGE. MILD BLEEDING: 22.1%. MODERATE BLEEDING: 5.3%.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 18751496 ↗
• InjuryJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ALTHOUGH THE PATIENT IS UNDER FOLLOW-UP OBSERVATION, NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH THE PATIENT REPORTEDLY HAS OTHER ILLNESSES, THERE HAS BEEN NO INDICATION THAT THE PATIENT EXPERIENCED A CHANGE IN HEALTH STATUS DUE TO THE LOSS OF THE OPAQUE MARKER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18552600 ↗
• InjuryDec 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING CLINICAL PRACTICE, THE OPAQUE TIP AT THE TIP OF SINGLE USE GUIDE SHEATH KIT, MODEL K-201 FELL INTO THE PATIENTS LUNGS. THE CHIP THAT FELL OFF HAS BEEN RECOVERED. THE PROCEDURE WAS EXTENDED BY TWO HOURS. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318853 ↗
• InjuryNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS CONFIRMED THAT THE DEVICE TIP FELL INSIDE THE PATIENT'S BODY. ALTHOUGH SPECIFIC DETAILS REGARDING THE REPORTED EVENT WERE REQUESTED BY OLYMPUS, THE ADDITIONAL REQUESTED INFORMATION WAS REPORTED AS UNKNOWN BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107089 ↗
• InjuryNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  HE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT THE OPAQUE MARKER FELL OFF AND WAS LOST IN BRONCHUS (EXACT LOCATION IS UNKNOWN) DUE TO SUCTION DURING A DIAGNOSTIC BRONCHIAL BIOPSY PROCEDURE. IT WAS DIFFICULT TO RETRIEVE THE MARKER WITH FORCEPS, SO THE PHYSICIAN APPLIED SUCTION WITH A SCOPE AND WAS ABLE TO RETRIEVE IT SUCCESSFULLY. THE MARKER WAS COLLECTED AND THEN CONFIRMED THAT IT WAS IN THE SUCTION BOTTLE. THE PHYSICIAN COMPLETED THE PROCEDURE BY SWITCHING TO ANOTHER IDENTICAL PRODUCT. THERE WAS A DELAY IN THE PROCEDURE LONGER THAN USUAL, HOWEVER THE TIME OF DELAY IS UNKNOWN. NO ADDITIONAL ANESTHESIA WAS GIVEN. NO REPORT OF ADDITIONAL MEDICAL/DIAGNOSTIC INTERVENTIONS UNDERTAKEN TO INVESTIGATE THE ISSUE. NO REPORT OF SIDE EFFECTS OR COMPLICATIONS FROM THE PROCEDURE. THERE WAS NO DETERIORATION OF THE PATIENT'S CONDITION AND NO HEATH DAMAGE TO THE PATIENT WAS REPORTED. THE DEVICE WAS INSPECTED PRIOR TO USE AND HAD NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089101 ↗
• InjuryOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IMPERMEABLE MARKER AT THE TIP OF THE SINGLE USE GUIDE SHEATH FELL OFF INTO THE PATIENT'S BODY DURING THE THERAPEUTIC ENDOBRONCHIAL ULTRASOUND USING GUIDE-SHEATH (EBUS-GS) PROCEDURE. THE DISLODGED PART WAS MOST LIKELY LEFT BEHIND IN THE PATIENT'S BODY. ADDITIONALLY, THE DOCTOR WHO USED THE DEVICE POINTED OUT THAT THE GUIDE SHEATH FELT LONGER THAN USUAL. AN APPROACH WAS MADE WITH A NEW SIMILAR DEVICE HOWEVER, IT WAS DIFFICULT AND THE PROCEDURE WAS NOT COMPLETED. SINCE A DIAGNOSIS WAS ALREADY OBTAINED, THE USER GAVE UP EARLY WITHOUT OVERDOING IT. AN ADDITIONAL OPERATION WAS CARRIED OUT AS ORIGINALLY PLANNED WITHOUT A RELATIONSHIP TO THIS EVENT. FOLLOW UP IMAGING WAS NOT PERFORMED TO DETERMINE THE STATUS OF THE FOREIGN BODY LEFT IN THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17855874 ↗
• InjurySep 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT WAS CONFIRMED THAT AN INDUCTOR AND BIOPSY FORCEPS WERE USED. ALL OTHER REQUESTED INFORMATION WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818202 ↗
• InjuryJul 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONFIRMED THE LOCATION TREATED IN THE LUNGS B8 OR B9 IN LOWER LOBE OF THE RIGHT LUNG AND THE DEVICE FELL OFF WHEN IT WAS INSERTED INTO THE PERIPHERY CALLED THE ESCAPE ON THE LEFT SIDE. THE INITIAL SCHEDULED TIME FOR THE CASE WAS 30 MINUTES, BUT IT OCCURRED 15 MINUTES AFTER THE START. THE SCHEDULED PROCEDURE WAS INTERRUPTED, AND THE DROPPED CHIP COULD NOT BE COLLECTED EVEN AFTER SPENDING 1 HOUR. NO ADDITIONAL PROCEDURE BEEN SCHEDULED TO RETRIEVE THE TIP AND NO POST-OPERATIVE FOLLOW-UP BIOPSY PROCEDURE HAVE BEEN COMPLETED AFTER IT WAS CANCELLED. CLIP REMOVAL WAS THE ADDITIONAL MEDICAL INTERVENTION REQUIRED AS A RESULT AS A RESULT OF THE TIP FALLING OFF. THERE WERE NO ADVERSE HEALTH EFFECTS, BUT THE BIOPSY WAS COMPLETED IN THE MIDDLE OF THE PROCEDURE. THE PATIENT HAS HAD A RESPIRATORY PROCEDURE (DETAILS UNKNOWN) IN THE PAST.

  Patient problems: Fever; Foreign Body In Patient

  MAUDE report 17423891 ↗
• MalfunctionJun 15, 2023Break; Break

  A USER FACILITY REPORTED TO OLYMPUS THAT THE SINGLE USE GUIDE SHEATH KIT CYTOLOGY BRUSH TIP BROKE DURING AN UNKNOWN THERAPEUTIC PROCEDURE. IT WAS REPORTED THAT THE BRUSH WAS RECOVERED, AND THERE WAS NO DROPOUT OR RESIDUE IN THE BODY. ADDITIONAL INFORMATION RECEIVED THAT THE BROKEN BRUSH TIP WAS IN THE FORCEPS CHANNEL OF THE SCOPE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134650 ↗
• InjuryJun 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT WHEN THE DOCTOR REMOVED THE GUIDE SHEATH AFTER A DIAGNOSTIC BRONCHOSCOPY USING AN EVIS LUCERA ELITE BRONCHOVIDEOSCOPE, THE TIP MARKER WAS NOTED TO BE MISSING. THE TIP MARKER WAS CONFIRMED TO HAVE FALLEN IN THE PATIENT'S BODY THROUGH X-RAY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH A SHORT DELAY TO COLLECT THE BROKEN PIECE. THE PATIENT HAD RECOVERED AND THERE WAS NO HARM TO THE PATIENT'S HEALTH. THE USER FELT THAT THE SCOPE'S CORRUGATED TUBE WAS CRUSHED AND THAT THE CLEANING BRUSH WAS NOT INSERTABLE, AND THAT THE CHANNEL LUMEN WAS NARROW. THE OLYMPUS REPRESENTATIVE WANTED TO CONFIRM IF THIS WAS RELATED TO THE DROPOUT OF THE TIP MARKER. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE GUIDE SHEATH. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE EVIS LUCERA ELITE BRONCHOVIDEOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099865 ↗
• InjuryMay 19, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A DIAGNOSTIC GENERAL SURGERY PROCEDURE USING THIS SINGLE USE GUIDE SHEATH, WHEN THE USER INSERTED THE BRUSH INTO THE GUIDE SHEATH, THE IMPERMEABLE TIP AT THE TIP FELL OUT INTO THE PATIENT'S BRONCHI. THE PROCEDURE COULD NOT BE COMPLETED AND THE IMPERMEABLE CHIP WILL BE RECOVERED BY SURGERY AT A LATER DATE. AS REPORTED, IT IS A LUNG CANCER AND CUSTOMER PLANS TO REMOVE THE MALIGNANT TUMOR AT THE SAME TIME AS RESECTION. THE DEVICE WAS INSPECTED BEFORE USE AND FELT A LITTLE KINK AT THE FRONT OF THE IMPERMEABLE TIP. ADDITIONAL INFORMATION OBTAINED THAT THE PATIENT REFUSED TO REMOVE THE TUMOR AND WAS DISCHARGED WITHOUT REMOVING THE TUMOR AND THE IMPERMEABLE CHIP. THERE WERE NO REPORTS OF ANY WORSENING OF PATIENT'S CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16970317 ↗
• InjuryMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AS USUAL. THE PATIENT WAS UNDER SEDATION DURING THE PROCEDURE; HOWEVER, THE TYPE OF ANESTHESIA IS UNKNOWN. ALTHOUGH THERE WAS NO PATIENT INJURY OR HARM, THE DEVICE TIP WAS NOT RETRIEVED FROM THE PATIENT. THERE WAS NO PROCEDURAL DELAY DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16948883 ↗
• InjuryMay 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE IMPERMEABLE RADIOPAQUE TIP OF A K-201 GUIDE SHEATH FELL OFF INTO THE PATIENT'S AIRWAY, LATER THE SAME DAY BEING LOCATED BY FLUOROSCOPY IN THE RIGHT LUNG'S PERIPHERY. THE FOREIGN OBJECT COULD NOT BE IMMEDIATELY COLLECTED AND WAS LEFT IN THE PATIENT, SINCE THE PATIENT APPARENTLY CHOKED (I.E. HAD DIFFICULTY BREATHING) DURING A FIRST RETRIEVAL ATTEMPT. THE FIRST PROCEDURE WAS COMPLETED. HOWEVER, THE POINT REACHED WAS THE LIMBUS, AND THE INDUCTOR WAS USED AGAIN TO ACHIEVE A BETTER POINT OF ARRIVAL. MIDAZOLAM AND FENTANYL WAS USED. THE PATIENT WAS UNDER CONSTANT SEDATION, ADDING MORE IF THE SEDATION BECAME TOO WEAK. ADDITIONAL INFORMATION INDICATES THERE WAS DEBRIS PRESENT IN OR AROUND GROUND GLASS AND SOME NODULAR LESIONS HAD NOT BEEN RETRIEVED FROM THE PATIENT. ADDITIONAL HOSPITAL VISITS TO UNDERGO CT SCANS FOR OBSERVATION WERE SCHEDULED. OF NOTE BEFORE USE, THE ECHO PROBE WAS INSERTED TO MAKE SURE THERE WERE NO PROBLEMS.

  Patient problems: Choking; Foreign Body In Patient

  MAUDE report 16942992 ↗
• InjuryMar 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE IMPERMEABLE TIP OF THE SINGLE USE GUIDE SHEATH FELL OFF INTO THE PATIENT'S PERIPHERAL BRONCHI DURING BRONCHIAL ENDOSCOPY. THE PHYSICIAN ATTEMPTED TO RETRIEVE IT BUT WAS UNABLE TO DO SO AS IT HAD FALLEN INTO THE PERIPHERAL END. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO FURTHER INTERVENTION, AND THE PATIENT WAS DISCHARGED AS SCHEDULED WITH A PLAN FOR FLUOROSCOPY CHECKS ABOUT ONCE A WEEK. THE PATIENT WAS ALSO SCHEDULED FOR LUNG RESECTION FOR LUNG CANCER WITH THE INTENTION TO REMOVE THE FALLEN TIP AT THAT TIME. THE PATIENT CURRENTLY HAD NO PARTICULAR ISSUES FROM THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624156 ↗
• InjuryMar 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE RADIOPAQUE MARKER FELL OFF FROM THE SINGLE USE GUIDE SHEATH DURING AN ENDOBRONCHIAL ULTRASOUND. THIS OCCURRED WHEN THE ATTACHED BIOPSY FORCEPS WERE INSERTED INTO THE GUIDE SHEATH AND THE FIRST CYTOLOGICAL EXAMINATION WAS PERFORMED. AT THIS POINT, THE GUIDE SHEATH HAD BEEN INSERTED INTO THE BRONCHOSCOPE AND THE INSIDE OF THE BRONCHI HAD BEEN VISUALIZED. IT WAS NOT DETERMINED WHERE THE DROPPED OPAQUE MAKER WAS. SINCE THERE WAS NO CHANGE IN THE PATIENT'S CONDITION, THE PROCEDURE WAS COMPLETED WITHOUT RETRIEVING THE OPAQUE MARKER. THE PATIENT WAS HOSPITALIZED; HOWEVER, THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION DONE ASIDE FROM A PLANNED FOLLOW UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 16475593 ↗
• MalfunctionFeb 24, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE INSERTION FORCEPS OF THE SINGLE USE GUIDE SHEATH KIT FOLDED AND IT BECAME DIFFICULT TO INSERT THE ECHO PROBE TO LOCATE THE SURGICAL SITE. THE PROCEDURE WAS PROLONGED AS A RESULT OF THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16437446 ↗
• InjuryDec 28, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS AFTER AN ENDOBRONCHIAL ULTRASOUND-GUIDED SHEATH (EBUS-GS) PROCEDURE USING A SINGLE USE GUIDE SHEATH KIT, THE STAFF OF THE FACILITY CONFIRMED WITH AN X-RAY THAT THE IMPERMEABLE TIP OF SHEATH HAD FALLEN INTO THE PATIENT'S BRONCHI. NO ADDITIONAL MEASURES SUCH AS RECOVERY OF THE IMPERMEABLE CHIP ARE BEING IMPLEMENTED AT THIS TIME, AND THE PROGRESS WILL BE OBSERVED. NO HEALTH ISSUES AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 16063002 ↗