MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC FLEX-XC; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 11278VU

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 09/02/2016

Event Type  malfunction  

Event Description

While cleaning and testing the digital ureteroscope for the next surgical case, the spd technologist noted the ureteroscope developed a greater than 10mmhg leak during the leak test.The underwater test noted pin hole leak 40mm from distal end.Scope has not been in service especially long.Unit brought to biomedical for evaluation and reporting.Manufacturer response for digital video ureteroscope, (brand not provided) (per site reporter): manufacturer suggested that failure may have been contributed by laser firing while still inside the flexible scope lumen during the procedure.Biomedical requested additional testing and evaluation based on the size of the pinhole leak that occurred.Biomedical stating that size of pinhole leak not indicative of lasing action.This was the third occurrence of pinhole leaks developing on the bending rubber section of the scope.

• Brand Name: FLEX-XC
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC; 2151 e. grand ave; el segundo CA 90245
• MDR Report Key: 5959491
• MDR Text Key: 55022943
• Report Number: 5959491
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11278VU
• Device Catalogue Number: R11278VU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2016
• Device Age: 18 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1