MAUDE Adverse Event Report: KARL STORZ FLEX-X FLEXIBLE URETOSCOPE; URETEROSCOPE

Model Number 11278AU1

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/21/2015

Event Type  malfunction  

Event Description

Physician reported that the scope was "bunched up." uncertain as to how damage occurred.There was no visible scope damage prior to use.Manufacturer response for flexible ureteroscope, flex-x flexible ureteroscope (per site reporter): major damage to angle cover (torn apart) caused by cleaning/disinfection.

• Brand Name: FLEX-X FLEXIBLE URETOSCOPE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): KARL STORZ; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 5781713
• MDR Text Key: 49157317
• Report Number: 5781713
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2016

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
• Device Operator: Physician
• Device Model Number: 11278AU1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 86