MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE GUIDE SHEATH KIT

Model Number	K-203
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.The k-203 instruction manual in the ¿inspection of the guide sheath¿ and ¿appearance inspection¿ sections¿ warns users ¿make sure that the gs stopper has not moved out of position.Make sure that the instrument is free from any disconnected or loosed parts.¿.
Event or Problem Description
Olympus was informed that during a diagnostic bronchoscopy procedure, (sg-201c) the fluoro marker from the guide sheath was pushed out into the patient.The device fragment was retrieved with forceps.There was no unusual bleeding observed.There was no indication of an issue prior to the breakage.There was no medical or surgical intervention required.The physician was able to complete the procedure using the same equipment.The patient was discharged home in good condition.Additionally, the user facility reported that the kit was inspected prior to use with no abnormalities noted.

• Brand Name: SINGLE USE GUIDE SHEATH KIT
• Common Device Name: SINGLE USE GUIDE SHEATH
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8418948
• Report Number: 2951238-2019-00539
• Device Sequence Number: 1789909
• Product Code: EOQ
• UDI-Device Identifier: 04953170245503
• UDI-Public: 04953170245503
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K060243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K-203
• Device Lot Number: 8XK
• 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: 02/14/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1