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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The olympus representative reported on behalf of the customer that the impermeability marker tip on the single use guide sheath dropped into the bronchus during the endobronchial ultrasound (ebus) case.The tip was confirmed under fluoroscopy and collected by aspiration of the scope.The tip was not in a torn shape.The procedure was completed by replacing with similar equipment.There was no patient health hazard or harm reported.
Event or Problem Description
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.
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 customer¿s reported complaint was confirmed.Evaluation findings are as follows: there was no deformation of the x-ray opaque chip.The insertion site was compressively buckled approximately 800mm from the tip.The position where the x-ray opaque chip had been fixed from the fixation marks left on the tube was confirmed, but no abnormalities were found.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although the specific manufacturer date is unknown, based on the three-digit lit number it was determined that the device was manufactured in may 2023.Based on the results of the investigation, it is likely that reported issue was caused by 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.Furthermore, compression buckling also occurs when an attempt is made to pull out a treatment instrument (forceps, brush, inductor, biopsy needle) from the guide sheath in a state where the instrument cannot be retracted.Compression buckling occurred due to the force applied to the tube in the compressive direction.Although, 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 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 additional information added to b5, d4, and h4.Also, an update has been made to d9 and h4.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: 17818202
• Report Number: 9614641-2023-01400
• Device Sequence Number: 2480451
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 35K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHARP SPOON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown