MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. / GYRUS ACMI, INC. SEMI-RIGID URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number MR6-LA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/09/2023

Event Type  Injury  

Event Description

During a right side cystoscopy / stent exchange / ureteroscopy, after the old stent was removed.The provider placed a glidewire into the kidney.He then advanced the semi-rigid ureteral scope over the wire and was able to easily access the dilated ureter.While the provider was advancing, the tip of scope avulsed the mucosa within the ureter circumferentially.The ureteral scope was evaluated post op and there were no obvious abnormality of the tip of the scope.The scope was released to the olympus rep for further evaluation / repair.

• Brand Name: SEMI-RIGID URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. / GYRUS ACMI, INC.
• MDR Report Key: 16552450
• MDR Text Key: 311481964
• Report Number: MW5115772
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MR6-LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White