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	Foreign Body In Patient (2687)
Date of Event	12/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus representative reported on behalf of the customer, during a therapeutic bronchoscopy procedure using the single use guide sheath kit, the tip of the marker fell into the lung and was unable to be collected.The operation was stopped when the dropout was confirmed.The procedure and anesthesia were extended for 1 hour as the user could not concentrate on the procedure due to the dropout.The case was difficult and could not be completed.The doctor approached a branch that was quite deep.Due to the difficulty of the case, it is unclear if the procedure could have been completed without the occurrence of this event.The operation may be continued in the future but a scheduled date has not been determined.An inductor was used in the procedure, and it is likely the biopsy forceps and brushes that come with the sheath were used too.There was no impact to the patient.
Additional Manufacturer Narrative
The guide sheath was returned for evaluation.Biopsy forceps, cytology brushes, and the radiopaque tip were not returned.The customers allegations were confirmed as the radiopaque tip was detached form the tube of the guide sheath.The position where the radiopaque tip was secured in place was verified by the marks left on the tube where the radiopaque tip was attached.The distal end of the tube was collapsed.No other abnormalities that could lead to the reported event were observed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported event (detachment of x-ray tip/device falling off into patient) was likely due to the following mechanism: 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, the devices caught on the radiopaque tip and fell off.Furthermore, the distal end of the tube collapsed, and a force was applied to the distal end of the tube and the radiopaque tip.This caused the radiopaque tip to detach from the tube.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) 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 angulation 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.¿ this supplemental report includes information added to b5.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that although the patient is under follow-up observation, no medical intervention was required.Although the patient reportedly has other illnesses, there has been no indication that the patient experienced a change in health status due to the loss of the opaque marker.

• 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: 18552600
• Report Number: 9614641-2024-00144
• Device Sequence Number: 7587049
• 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): 03/01/2024

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: 38K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• 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: 12/25/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: BRUSH, BIOPSY FORCEPS; INDUCTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian