MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE GUIDE SHEATH KIT

Model Number	K-201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fever (1858); Foreign Body In Patient (2687)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the single use guide sheath kit tip came off inside a patient.The issue occurred during a post-operative, follow-up biopsy in the lungs.After the tissue sample was collected, the procedure was extended by 30-minutes while the user attempted to collect the tip.A fluoroscopic diagnosis was later performed which confirmed the tip was still in the peripheral pulmonary branch of the lungs and would not negatively impact the patient.The physician opted not to do another invasive surgery in an attempt to retrieve the device tip and decided to allow it to remain in the patient.The patient developed a fever after the procedure, but it is unclear whether the fever was related to the prolonged procedure.The patient was discharged as planned, but their condition is unknown.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and evaluation with corrections to the initial with information inadvertently left out.The subject device was manufactured in march 2023, but the specific date is unknown.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: the radiopaque chip was sent with the chip removed.The position where the radiopaque tip was fixed was confirmed from the marks left on the tube by the radio paque tip fixation, but no abnormality was found.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the phenomenon "additional endoscopic procedures increase the burden on the patient" occurred because the radiopaque tip fell out of the body.The root cause of the phenomenon could not be identified.Additionally, it is likely the phenomenon "dropping off of the x-ray opaque tip" occurred through the following mechanism: 1.) when the inductor was inserted, the tip of the inductor was in a bent state.2.) the inductor joint was caught on the x-ray opaque tip.3.) the actuator was moved forward and backward while the joint of the inductor was caught by the x-ray opaque tip, and the guide sheath was pulled in the pulling direction.4.) the x-ray opaque tip was pushed and pulled while being caught by the inductor, and the position of the x-ray opaque tip was displaced.5.) since the x-ray opaque tip was slanted with respect to the tube, when the inductor was projected, it was caught by the x-ray opaque tip and fell off.The root cause of the phenomenon could not be determined.The event can be prevented by following the instructions for use which state: "when inserting a procedure tool or ultrasound probe into a guide sheath outside the endoscope, when inserting a procedure tool or ultrasound probe into a guide sheath inserted into the endoscope, when advancing or retracting a procedure tool or ultrasound probe in the guide sheath, or when withdrawing a procedure tool or ultrasound probe from the guide sheath, in the case of an inductor do so slowly with the tip of the inductor straightened, with the cup of the biopsy forceps closed in the case of biopsy forceps, and with the brush portion retracted into the tube in the case of cytology brushes.If any abnormal tugging or resistance is felt, do not protrude the instrument or ultrasound probe from the tip of the guide sheath, and discontinue use immediately.[the radiopaque tip of the guide sheath may become misaligned or fall out.]" "when using a guide sheath or other device, do not apply a strong angle to the endoscope.If it is difficult to insert the guide sheath and the ultrasonic probe or procedure tool inserted into the guide sheath into or withdraw from the endoscope due to high resistance, or if the ultrasonic probe or procedure tool cannot be withdrawn from the guide sheath, return the angle of the endoscope to a point where it can be inserted or withdrawn without difficulty if the patient is still unable to pull it out, the angle of the endoscope should be returned to the point where it can be inserted or pulled out without difficulty.If it still cannot be pulled out, the guide sheath, ultrasound probe or procedure instrument, and endoscope should be pulled out of the patient together.[the radiopaque tip of the guide sheath may become misaligned or fall out.Or other damage to the instrument could occur]." "when inserting an ultrasound probe or procedure tool into a guide sheath inserted into an endoscope, move the guide sheath slowly within the endoscope's field of view or under x-ray fluoroscopy, and check for any abnormalities such as misalignment or dislocation of the radiopaque tip in the guide sheath before each insertion.If any abnormality is suspected, discontinue use." "after the guide sheath is withdrawn from the endoscope, whether or not the guide sheath is inserted back into the endoscope, check the guide sheath each time for any abnormalities such as buckling or tearing of the tubing, misalignment of the radiopaque tip, or loss of the radiopaque tip.If any abnormality is suspected, do not use the guide sheath; if the radiopaque tip has fallen out, check to see if it has not fallen out inside the body." "if there is significant resistance when inserting the instrument into the guide sheath, do not force the instrument into the sheath.Also, do not insert the biopsy forceps with the cup open or the brush portion of the cytology brush protruding from the tube.Doing so may result in damage to the endoscope and this product." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE GUIDE SHEATH KIT
• Common Device Name: SINGLE USE GUIDE SHEATH
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17423891
• Report Number: 9614641-2023-01053
• Device Sequence Number: 7657169
• Product Code: EOQ
• UDI-Device Identifier: 04953170245466
• UDI-Public: 04953170245466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K-201
• Device Lot Number: 33K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOSCOPE BF-XP260F; SINGLE USE GUIDING DEVICE CC-6DR-1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male