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

Model Number K-201

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Choking (2464); Foreign Body In Patient (2687)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

The device was sent to olympus for evaluation.Upon inspection testing of the returned device, the user's request was not confirmed.However, 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 present.There were numerous scratches near the radiopaque tip of the guide sheath the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the impermeable radiopaque tip of a k-201 guide sheath fell off into the patient's airway, later the same day being located by fluoroscopy in the right lung's periphery.The foreign object could not be immediately collected and was left in the patient, since the patient apparently choked (i.E.Had difficulty breathing) during a first retrieval attempt.The first procedure was completed.However, the point reached was the limbus, and the inductor was used again to achieve a better point of arrival.Midazolam and fentanyl was used.The patient was under constant sedation, adding more if the sedation became too weak.Additional information indicates there was debris present in or around ground glass and some nodular lesions had not been retrieved from the patient.Additional hospital visits to undergo ct scans for observation were scheduled.Of note before use, the echo probe was inserted to make sure there were no problems.

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.Based on the results of the investigation from past reproduction studies, although the root cause could not be determined, the reported event likely occurred through 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.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿when inserting a therapeutic instrument or ultrasonic probe into a guide sheath outside the endoscope, inserting a therapeutic instrument or ultrasonic probe into a guide sheath inserted into an endoscope, when moving the probe forward or backward, or when pulling out the treatment instrument or ultrasound probe from the guide sheath, hold the tip of the inductor if it is an inductor.¿ ¿when using a guide sheath, etc., do not bend the endoscope strongly.If the guide sheath and the ultrasound probe or treatment instrument inserted in the guide sheath are difficult to insert or remove from the endoscope due to high resistance, the ultrasound probe or treatment instrument cannot be pulled out from the guide sheath.In that case, return the angle of the endoscope to the point where it can be inserted and withdrawn without difficulty.If it still cannot be pulled out, pull out the guide sheath, ultrasound probe or therapeutic device, and endoscope together from the patient.[the x-ray opaque tip of the guide sheath may become misaligned or fall off.Or other damage to the equipment may occur.]¿ ¿when inserting an ultrasonic probe or therapeutic instrument into a guide sheath inserted into an endoscope, move the guide sheath slowly within the field of view of the endoscope or under x-ray fluoroscopy to ensure that the radiopaque tip inside the guide sheath insert after confirming every time that there is no abnormality such as misalignment or disconnection.Discontinue use if any abnormality is suspected.¿ ¿after the guide sheath is withdrawn from the endoscope, regardless of whether or not the guide sheath is reinserted into the endoscope, the guide sheath may cause buckling or tearing of the tube, displacement of the radiopaque tip, or detachment.Always check that there are no abnormalities such as do not use if any abnormality is suspected.If the x-ray opaque tip has fallen off or inside the body, check to see if it has fallen off inside the body.¿ ¿do not force the instrument into the guide sheath if there is significant resistance.Also, do not insert the biopsy forceps with the cup open or the brush portion of the cytology brush protruding from the tube.It may damage the endoscope and this product.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE GUIDE SHEATH KIT
• Type of Device: 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: 16942992
• MDR Text Key: 315354862
• Report Number: 9614641-2023-00677
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170245466
• UDI-Public: 04953170245466
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K-201
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male