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

Model Number	K-201
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.This report is linked to the following patient identifier: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during a guided sheath procedure the guide sheath was attempted to be passed through the scope but did not protrude from the tip of the scope as expected.The tip fell off and the fallen pieces were immediately recovered using grasping forceps.The procedure was completed using a similar device.There was no reported harm to patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The subject device was discarded by the customer and not returned to olympus.However, two sets of the device with the same lot number were returned to olympus for evaluation.It was confirmed that the radiopaque tip of the subject device was detached form the tube of the guide sheath.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was manufactured in august 2023.Based on the results of the investigation, the reported event (detachment of the radiopaque tip) was likely due to the distal end of the inductor being extended and retracted in a curved position.The likely mechanism is as follows: 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.A force was applied to the distal end of the tube and the radiopaque tip which caused the radiopaque tip to detach from the tube.However, the root cause 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 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.¿ this supplemental report includes a correction to b5 and g2 to include information that was inadvertently not included in the initial medwatch.Also, a correction has been made to h6 (type of investigation) from the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the physician attempted to push and pull the guide sheath several times but was still unable to protrude the tip of the guide sheath from the endoscope.The tip fell off and into the patient¿s lung; however, the specific area of the lung is unknown.

• 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: 18764114
• Report Number: 9614641-2024-00453
• Device Sequence Number: 4462560
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 02/15/2024
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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: BF-P290.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown