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 Problem Foreign Body In Patient (2687)

Event Date 12/25/2023

Event Type  Injury  

Event 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.

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.

• 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: 18552600
• MDR Text Key: 333362502
• Report Number: 9614641-2024-00144
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 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
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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
• Treatment: BRUSH, BIOPSY FORCEPS; INDUCTOR
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian