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	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon evaluation of the returned device, it was confirmed that the radiopaque tip was removed from the tube of the guide sheath.From the fixation marks of the radiopaque chip remaining on the tube, it was confirmed there was no abnormality based on the fixation position.The suction bottle that was utilized for collection was sent along with the actual product.No visual abnormalities such as crushing on the opaque chips were confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.The subject device was manufactured in june 2023 based on the provided 3 digit lot information "36k".
Event or Problem Description
He olympus employee reported on behalf of the customer that the opaque marker fell off and was lost in bronchus (exact location is unknown) due to suction during a diagnostic bronchial biopsy procedure.It was difficult to retrieve the marker with forceps, so the physician applied suction with a scope and was able to retrieve it successfully.The marker was collected and then confirmed that it was in the suction bottle.The physician completed the procedure by switching to another identical product.There was a delay in the procedure longer than usual, however the time of delay is unknown.No additional anesthesia was given.No report of additional medical/diagnostic interventions undertaken to investigate the issue.No report of side effects or complications from the procedure.There was no deterioration of the patient's condition and no heath damage to the patient was reported.The device was inspected prior to use and had no problem.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.The subject device was manufactured in june 2023, but the specific date is unknown.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 mechanism causing the reported event (detachment of the radiopaque tip) could be the following: 1) the inductor tip was bent when the inductor was inserted.2) the inductor joint was caught on the radiopaque tip.3) the inductor was pushed and pulled while the inductor joint was caught on the radiopaque tip.Or, the guide sheath was pulled in the pulling direction.4) the radiopaque tip was pushed and pulled while it was caught on the inductor, causing the radiopaque tip position to be dislocated.5) the radiopaque tip was displaced at an angle to the tube.Therefore, when the inductor or instruments were extended, they caught on the radiopaque tip and fell off.However, the root cause of the reported event could not be specified.The event can be prevented by following the instructions for use which state: "do not force the instrument if resistance to insertion is encountered.Reduce the angulation until the instrument passes smoothly.Forcing the instrument could cause patient injury, such as punctures, hemorrhages or mucous membrane damage, and could damage the endoscope and/or instrument." "while the ultrasound probe or endotherapy is inserted into the guide sheath, do not force the endoscope or guide sheath.Doing so could result in bending or breaking of endotherapy and/or ultrasound probe." "do not insert the endotherapy into the guide sheath, if the forceps cups are open or if the cytology brush is extended from the distal end of the tube.Doing so could damage the endoscope and/or instrument." "do not withdraw the endotherapy from the guide sheath if resistance to withdrawal is encountered.Reduce the angualtion of the endoscope and withdraw the endotherapy and the guide sheath together from the endoscope." "if excessive resistance makes withdrawal difficult, adjust the angulation of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal could damage the endoscope and/or instrument." 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: 18089101
• Report Number: 9614641-2023-01670
• Device Sequence Number: 20521539
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 36K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown