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

Model Number 11278 VU

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 07/13/2016

Event Type  malfunction  

Event Description

The cysto scope failed the leak test after the surgery and before it was processed by sterile processing.We have had 12 broken scopes including most with failed leak tests in the past 7 months.We only own 2 scopes so several have been replaced several times.We have had the vendor watch 2 days of cases and nothing failed during those 2 days.Manufacturer response for cysto fiber scope, (brand not provided) (per site reporter): they are evaluating the device for defects and operator abuse.They stated that the scopes have an average of 10 uses before some form of repair is needed.

• Brand Name: FLEX-XC
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 5916999
• MDR Text Key: 53658151
• Report Number: 5916999
• 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: Other
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11278 VU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1