Single Use Guide Sheath Kit K-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170245503), received between Mar 13, 2019 and Apr 22, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED OF THE FOLLOWING LITERATURE: CASE REPORT HISTOPATHOLOGICAL EXAMINATION OF BIOPSY SCARS BY CRYOBIOPSY. TRANSBRONCHIAL BIOPSY (TRANSBRONCHIAL BIOPSY : TBB) HAS BEEN PERFORMED FOR MANY YEARS IN THE HISTOLOGICAL DIAGNOSIS OF LUNG CANCER, AND VARIOUS DEVICES HAVE BEEN DEVELOPED TO IMPROVE THE DIAGNOSTIC ACCURACY. IN 2017, A CRYOPROBE WAS APPROVED IN (B)(6), AND BIOPSY USING A CRYOPROBE (CRYOBIOPSY) IS NOW WIDELY PERFORMED. FLEXIBLE BRONCHOSCOPY WAS PERFORMED USING A BF-1TQ290 OR BF-1T260 WITH A 1.9-NM CRYOPROBE INSERTED THROUGH 201CGS SHEATH (255-MMSG-GUIDESHEATH) AND A CRYO-BIOPSY. ALTERNATIVELY, A 1.9-MM CRYOPROBE WAS INSERTED DIRECTLY INTO BF-P290 AND A CRYO-BIOPSY WAS PERFORMED. SPECIMENS WERE COLLECTED AFTER A FREEZING TIME OF APPROXIMATELY 3S WITH SIMULTANEOUS REMOVAL OF THE FLEXIBLE BRONCHOSCOPE AND CRYOPROBE. HEMOSTASIS WAS PERFORMED BY DOUBLE FIBER METHOD. THE DEVICES USED IN THE PROCEDURES WERE SG-201C GS, BF-1T260 AND BF-P290. THE BF-1T260 WAS REMOVED DURING THE PROCEDURE AND REPLACED WITH BF-P290 TO DO THE CRYO-BIOPSY IN THE TWO CASES. TWO PATIENTS EXPERIENCED ADVERSE EVENTS INVOLVING BF-P290 AND SG-201C GS. (B)(6) WAS A FEMALE IN HER 60S WITH A BLEED AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13508325 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED OF THE FOLLOWING LITERATURE: CASE REPORT HISTOPATHOLOGICAL EXAMINATION OF BIOPSY SCARS BY CRYOBIOPSY. TRANSBRONCHIAL BIOPSY (TRANSBRONCHIAL BIOPSY: TBB) HAS BEEN PERFORMED FOR MANY YEARS IN THE HISTOLOGICAL DIAGNOSIS OF LUNG CANCER, AND VARIOUS DEVICES HAVE BEEN DEVELOPED TO IMPROVE THE DIAGNOSTIC ACCURACY. IN 2017, A CRYOPROBE WAS APPROVED IN (B)(6), AND BIOPSY USING A CRYOPROBE (CRYOBIOPSY) IS NOW WIDELY PERFORMED. FLEXIBLE BRONCHOSCOPY WAS PERFORMED USING A BF-1TQ290 OR BF-1T260 WITH A 1.9-NM CRYOPROBE INSERTED THROUGH 201CGS SHEATH (255-MMSG-GUIDESHEATH) AND A CRYO-BIOPSY. ALTERNATIVELY, A 1.9-MM CRYOPROBE WAS INSERTED DIRECTLY INTO BF-P290 AND A CRYO-BIOPSY WAS PERFORMED. SPECIMENS WERE COLLECTED AFTER A FREEZING TIME OF APPROXIMATELY 3S WITH SIMULTANEOUS REMOVAL OF THE FLEXIBLE BRONCHOSCOPE AND CRYOPROBE. HEMOSTASIS WAS PERFORMED BY DOUBLE FIBER METHOD. THE DEVICES USED IN THE PROCEDURES WERE SG-201C GS, BF-1T260 AND BF-P290. THE BF-1T260 WAS REMOVED DURING THE PROCEDURE AND REPLACED WITH BF-P290 TO DO THE CRYO-BIOPSY IN THE TWO CASES. TWO PATIENTS EXPERIENCED ADVERSE EVENTS INVOLVING BF-P290 AND SG-201C GS. CASE 1 WAS A FEMALE IN HER 60S WITH A BLEED AND

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13508310 ↗
• MalfunctionJul 3, 2019Break; Break

  OLYMPUS RECEIVED A MEDWATCH REPORT. THE MEDWATCH STATED, " DURING TRANSBRONCHIAL CRYOBIOPSY INTERVENTIONAL PROCEDURE. THE RIGID BRONCHOSCOPE WAS FIRST WEDGED INTO THE LINGULA, WHERE NORMAL SALINE WAS INSTILLED FOR RETURN OF CLOUDED LAVAGE FLUID. NEXT, THE 1.9MM CRYOPROBE WAS FED THROUGH A 2.6MM OLYMPUS GUIDESHEATH, THAT WAS GUIDED TO THE POSTERIOR SEGMENT LEFT UPPER LOBE VIA A PAIR OF FLEXIBLE FORCEPS IN THE WORKING CHANNEL OF THE BRONCHOSCOPE AND VISUALIZED BY FLUOROSCOPY. A 5FR FOGARTY BALLOON WAS POSITIONED IN THE DIVISION, THEN INFLATED AFTER A FREEZE ON THE CRYOPROBE OF 10 SECONDS AND REMOVED TO THAW TISSUE IN SALINE THAT WAS THEN PLACED IN FORMALIN. THIS WAS REPEATED AGAIN IN THE APICAL DIVISION OF THE LEFT UPPER LOBE, AND ANOTHER CRYOBIOPSY WAS OBTAINED USING THE SAME METHOD FROM THE POSTERIOR SEGMENT OF THE LEFT UPPER LOBE. DURING THE POSITIONING, IT WAS NOTED THAT THE DISTAL RADIO-OPAQUE TIP OF THE GUIDE SHEATH WAS MISSING. USER SCANNED THE PATIENT'S CHEST TO ENSURE THAT THE PIECE HAD NOT FALLEN OFF INTO THE AIRWAY. THE ORIGINAL INTENDED PROCEDURE WAS FLEXIBLE BRONCHOSCOPY WITH TRANSBRONCHIAL CRYOBIOPSY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8759203 ↗
• MalfunctionMar 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, (SG-201C) THE FLUORO MARKER FROM THE GUIDE SHEATH WAS PUSHED OUT INTO THE PATIENT. THE DEVICE FRAGMENT WAS RETRIEVED WITH FORCEPS. THERE WAS NO UNUSUAL BLEEDING OBSERVED. THERE WAS NO INDICATION OF AN ISSUE PRIOR TO THE BREAKAGE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE USING THE SAME EQUIPMENT. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE KIT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418948 ↗