Single Use Guide Sheath KitRecalls & reported problems across all models

We found 4 models of Single Use Guide Sheath Kit by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Mar 13, 2019 and Feb 20, 2025 — classified as 1 death, 35 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Single Use Guide Sheath Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 4 of these models · Recall details · FDA record ↗

Most reported Single Use Guide Sheath Kit problems

Single Use Guide Sheath Kit models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Guide Sheath Kit K-201

  Bronchoscope (flexible or rigid)
  1 recall33 reports
• Single Use Guide Sheath Kit K-203

  Bronchoscope (flexible or rigid)
  1 recall5 reports
• Single Use Guide Sheath Kit K-202

  Bronchoscope (flexible or rigid)
  1 recall1 death4 reports
• Single Use Guide Sheath Kit K-204

  Bronchoscope (flexible or rigid)
  1 recall1 report

Recent Single Use Guide Sheath Kit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE FOR SUSPECTED PERIPHERAL LUNG CANCER, THE ULTRASONIC PROBE WAS USED IN COMBINATION WITH THE SINGLE-USE GUIDE SHEATH. UPON REMOVAL FROM THE PATIENT, IT WAS OBSERVED THAT APPROXIMATELY 5CM OF THE PROBE'S COATING HAD PEELED OFF. CT AND FLUOROSCOPY WERE IMMEDIATELY PERFORMED TO CHECK FOR RETAINED FRAGMENTS, AND NONE WERE DETECTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S CONDITION SUDDENLY DETERIORATED, REQUIRING EMERGENCY INTERVENTION. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL WHERE DEATH WAS CONFIRMED THE SAME DAY. THE CAUSE OF DEATH WAS DOCUMENTED AS UNKNOWN, AND NO ADDITIONAL INFORMATION REGARDING AUTOPSY FINDINGS OR CONTRIBUTING FACTORS WAS AVAILABLE. THERE WERE NO REPORTS OF PROCEDURAL COMPLICATIONS, IMMEDIATE POST-PROCEDURAL ADVERSE EVENTS, OR CONFIRMED DEVICE-RELATED INJURY. THERE WAS NO REPORTED MALFUNCTION OR ISSUE WITH THE SINGLE-USE GUIDE SHEATH.

  Patient problems: Insufficient Information

  MAUDE report 21426812 ↗
• 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 ↗
• InjuryApr 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT UNDERWENT A RADIAL PROBE ENDOBRONCHIAL ULTRASOUND USING A GUIDE SHEATH WITH A BOSTON SCIENTIFIC EXCELLON NEEDLE. DURING THE PROCEDURE THEY FELT A RESISTANCE. AFTER THE PROCEDURE, THE PATIENT WAS NOT COMFORTABLE AND WAS COUGHING. UPON DOING A SCAN THEY OBSERVED SOMETHING IN THE PATIENT'S LUNG. THE PATIENT DID ANOTHER BRONCHOSCOPY AND THEY RETRIEVED THE METAL RADIOPAQUE RING FROM THE DISTAL PART OF THE SUBJECT DEVICE. THE CUSTOMER LATER REPORTED DURING THE PATIENTS INITIAL EXAMINATION PART OF THE INSTRUMENT REMAINED IN THE PATIENT. THE PATIENT WAS READMITTED FIVE DAYS LATER FOR HEMOPTYSIS SECONDARY TO THE METALLIC FOREIGN BODY AND THE FOREIGN BODY WAS REMOVED UNDER GENERAL ANESTHESIA.

  Patient problems: Cough; Foreign Body In Patient; Hemoptysis

  MAUDE report 19161131 ↗
• InjuryApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE RADIOPAQUE TIP OF SINGLE USE GUIDE SHEATH WAS LEFT IN THE PATIENT'S BRONCHUS DURING A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT DEVICE RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19152531 ↗
• 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 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "COMPUTED TOMOGRAPHY BRONCHUS SIGN SUBCLASSIFICATION DURING RADIAL ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL BIOPSY: A RETROSPECTIVE ANALYSIS." THIS WAS A RETROSPECTIVE STUDY OF CONSECUTIVE PATIENTS WHO UNDERWENT RADIAL ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL BIOPSY (REBUS-TBB) FOR PERIPHERAL PULMONARY LESIONS BETWEEN NOVEMBER 2015 AND OCTOBER 2017. PATIENTS WITH CENTRAL PULMONARY LESIONS (PPLS) WITH EVIDENCE OF ENDOBRONCHIAL INVOLVEMENT, THOSE WHO UNDERWENT RE-EXAMINATION FOR THE SAME LESION, THOSE WITH UNKNOWN FINAL DIAGNOSIS DUE TO LOSS AT FOLLOW-UP, AND THOSE WITH LACK OF EVALUATION BY HIGH RESOLUTION CT (HRCT) IMAGING OF LESIONS THAT WERE LESS THAN 1MM IN THICKNESS WERE EXCLUDED. THE STUDY CONCLUDES THAT CT BRONCHUS SIGN SUBCLASSIFICATION MAY PROVIDE USEFUL INFORMATION TO FACILITATE THE SELECTION OF BRONCHOSCOPIC TECHNIQUES FOR ACCURATE DIAGNOSIS OF PPLS. REBUS-TBB GENERALLY HAD AN ACCEPTABLE DIAGNOSTIC PERFORMANCE IN CT-BS GROUP I. HOWEVER, TYPE IC IS EXCEPTIONAL, AND IT MAY BE USEFUL TO OBTAIN LARGER SAMPLES WITH A 1.9 MM FORCEPS (OR CONSIDER CRYOPROBES). REBUS-TBB IS NOT EXPECTED TO PROVIDE SUFFICIENT DIAGNOSTIC PERFORMANCE IN CT-BS

  Patient problems: Pneumothorax; Respiratory Tract Infection

  MAUDE report 18822565 ↗
• 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 ↗

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