MAUDE Adverse Event Report: OLYMPUS UROPASS URETERAL ACCESS SHEATH; ENDOSCOPE AND ACCESSORIES

Catalog Number EG61146BX

Device Problem Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2017

Event Type  Injury  

Event Description

While performing a cysto retrograde pyelogram, the tip of sheath on the ureteral access split while being used.

• Brand Name: UROPASS URETERAL ACCESS SHEATH
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 6843048
• MDR Text Key: 84951097
• Report Number: MW5071935
• Device Sequence Number: 1
• Product Code: KNY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EG61146BX
• Device Lot Number: 09F1600052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 84