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

Model Number	K-201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hemoptysis (1887); Hemorrhage/Blood Loss/Bleeding (1888); Hematemesis (4478)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the single use guide sheath kit was used during guided sheath procedure.The patient's condition "suddenly changed when the lungs were being lavaged after the biopsy." the patient "vomited a lot of blood." additional information obtained that bleeding occurred, causing a 1-hour delay for hemostasis.The procedure was then completed.The hospital commented that there was no problem with the olympus product and the biopsy itself.Further information received that confirmed no change to open surgery.Per the customer, there was a "possibility that the blood was aspirated because it took some time to aspirate after hemoptysis; the bleeding was probably from the biopsy site." the patient recovered well and appeared to be able to communicate the day after the procedure.
Additional Manufacturer Narrative
This report is related to patient identifiers: (b)(6).The evaluation of the event 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 and correction to the initial with information inadvertently left out (e1 and g2).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, the subject device was not returned, and a specific root cause could not be identified.The event can be prevented by following the instructions for use which state: "before use, prepare and inspect the instruments as instructed below.Should any irregularity be observed, do not use the instrument but use a spare instead.Damage or irregularity may compromise patient or operator safety by posing an infection-control risks, tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage." "do not force the distal end of the insertion portion against body cavity tissue.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage." "do not force the distal end of the insertion portion against body cavity tissue.If you press the instrument¿s cup too hard against tissue in an attempt to take a sample more than needed, the risk of perforation increase.Do not take more than needed." 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: 18956590
• Report Number: 9614641-2024-00749
• Device Sequence Number: 13097862
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: K-201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 SERIAL (B)(6); CLV-290; CV-290; UM-S20-17S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male