MAUDE Adverse Event Report: GYRUS-ACMI GYRUS-ACMI FLEXIBLE URETEROSCOPE

Model Number DUR-8

Device Problems Detachment Of Device Component (1104); Material Frayed (1262)

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

Event Date 06/21/2016

Event Type  Injury  

Event Description

While performing a cystoscopy and stone retraction, the end of the flexible ureteroscope frayed off.Dr.Dona was attempting to remove the kidney stone, pieces of the scope were noted in the pt, near the kidney.Dr dona was able to remove the pieces.The pieces of the scope and the scope were examined.Diagnosis or reason for use: left ureteral stent.Tip of scope broke off.

• Brand Name: GYRUS-ACMI FLEXIBLE URETEROSCOPE
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): GYRUS-ACMI
• MDR Report Key: 5781770
• MDR Text Key: 49248452
• Report Number: MW5063317
• Device Sequence Number: 1
• Product Code: FGB
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUR-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 59 YR
• Patient Weight: 91