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

Model Number	K-201
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has been returned to olympus but not yet evaluated.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the missing radiopaque tip was not sent for evaluation.The tip of the tube was completely crushed and deformed into an elliptical shape.The position where the x-ray opaque tip was fixed was confirmed from the fixation mark of the x-ray opaque tip left on the tube, but there was no abnormality.The insertion part was observed to be buckled at a point about 500mm from the tip.The tube was compressed and buckled near the hand.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, the reported issue was likely caused by the following mechanism: when the inductor was inserted, the tip of the inductor was in a bent state.The inductor joint was caught on the x-ray opaque tip.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.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.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.Furthermore, compression buckling of the tube is caused by trying to withdraw the instrument (forceps, brush, guide, biopsy needle) from the guide sheath in a state where it cannot be retracted.Compression buckling likely occurred due to the force applied to the tube in the compression direction.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿when inserting a treatment tool or ultrasonic probe into the guide sheath outside the endoscope, when inserting a treatment tool or ultrasonic probe into the guide sheath inserted into the endoscope, when inserting the treatment tool or ultrasonic probe into the guide sheath when moving the probe back and forth, and when pulling out the treatment tool or ultrasonic probe from the guide sheath, keep the tip of the inducer straight in the case of the inducer, and close the cup of the biopsy forceps in the case of the biopsy forceps.In the case of a biopsy brush, pull the brush part into the tube and do it slowly.If you feel any abnormal catch or resistance, do not stick out the treatment tool or ultrasonic probe from the tip of the guide sheath, and stop using it immediately.[the x-ray opaque tip of the guide sheath may be misaligned or fall off.] ¿when using a guide sheath, do not apply a strong angle to the endoscope.If the resistance is high and it is difficult to insert the ultrasonic probe or treatment tool inserted into the guide sheath and the guide sheath into the endoscope or pull it out from the endoscope, the ultrasonic probe or treatment tool cannot be pulled out from the guide sheath.If so, return the endoscope angle to the point where it can be inserted and removed without difficulty.If it still does not pull out, pull the guide sheath, ultrasound probe or procedure, and endoscope together from the patient.[the x-ray opaque tip of the guide sheath may be misaligned or fall off.Alternatively, other damage to the equipment may occur.]¿ ¿when inserting an ultrasonic probe or treatment tool into the guide sheath inserted into the endoscope, slowly move the guide sheath within the field of view of the endoscope or under fluoroscopy and insert the x-ray opaque tip inside the guide sheath.Insert after confirming that there are no abnormalities such as misalignment or dislocation.If any abnormality is suspected, discontinue use.¿ ¿after the guide sheath is pulled out from the endoscope, the tube buckles or tears in the guide sheath, the position of the x-ray opaque tip shifts, and the tip falls off regardless of whether or not the guide sheath is reinserted into the endoscope.Make sure that there are no abnormalities such as.Do not use it if any abnormality is suspected.If the x-ray opaque chip has fallen off, and if it has fallen into the body, check that it has not fallen into the body.¿ ¿when inserting the treatment tool into the guide sheath, do not force it if there is significant resistance.Also, do not insert the biopsy forceps with the cup open or with the brush part of the biopsy brush protruding from the tube.It may cause damage to the endoscope and this product.¿ this supplemental report includes an update to h3 from the initial medwatch.Also, a correction has been made to g2 to provide information that was inadvertently not included on the initial medwatch.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: 16063002
• Report Number: 9614641-2022-00863
• Device Sequence Number: 19344133
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 27K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown