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	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The guide sheath was returned to olympus for evaluation without the x-ray opaque tip.The tip of the tube was completely crushed and deformed into an ellipse.The position of the x-ray tip was confirmed from the fixation marks in the tube, but no abnormality was noted.There was buckling observed at about 73 millimeters (mm), 227 mm, 400 mm, and 870 mm from the tip.Inspection confirmed that the x-ray opaque tip had fallen out of the guide sheath; however, the reported event could not be reproduced as the x-ray opaque tip had already fallen out.Additional information has been requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information has been received.
Event or Problem Description
An olympus representative reported to olympus, on behalf of the customer, that the radiopaque marker fell off from the single use guide sheath during an endobronchial ultrasound.This occurred when the attached biopsy forceps were inserted into the guide sheath and the first cytological examination was performed.At this point, the guide sheath had been inserted into the bronchoscope and the inside of the bronchi had been visualized.It was not determined where the dropped opaque maker was.Since there was no change in the patient's condition, the procedure was completed without retrieving the opaque marker.The patient was hospitalized; however, there was no further medical or surgical intervention done aside from a planned follow up.
Additional Manufacturer Narrative
This report is being supplemented to report the additional information received as reflected in b5.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Additional information was received from an olympus representative on behalf of the customer.The patient was reportedly hospitalized before the bronchoscopy and remained hospitalized due to other unspecified diseases.The retained radiopaque marker did not prolong their hospitalization nor necessitate transfer.At this time, there was no particular effect on the patient's physical condition and no examination or diagnosis had been made to follow up on the radiopaque marker residuals.
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.Based on the results of the investigation, although the root cause could not be determined, the mechanism that likely caused the reported event is as follows: 1) when the guiding device was inserted into the guide sheath, the tip of the guiding device was bent.2) the joint of guiding device was caught in the radiopaque tip.3) the guiding device was moved forward and backward while the joint of the guiding device was caught in the radiopaque tip, or the guide sheath was pulled into the pulling direction.4) the guiding device was pushed and pulled while the radiopaque tip was caught in the guiding device.This caused the position of the radiopaque tip to displace.5) the radiopaque tip was misaligned diagonally with respect to the tube.Therefore, when the biopsy forceps were extended from the guide sheath, the biopsy forceps was caught in the radiopaque tip.As a result, the radiopaque tip detached from the tube.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.¿ 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
• 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: 16475593
• Report Number: 9614641-2023-00298
• Device Sequence Number: 7250057
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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: 28K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/07/2023; 04/26/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/14/2023; 05/11/2023
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 61 KG