MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. URETERO-RENO-FIBERSCOPE FLEX-X²; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number FLEX-X2S

Device Problems Loose or Intermittent Connection (1371); Physical Resistance/Sticking (4012)

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

Event Date 02/24/2020

Event Type  malfunction  

Event Description

The patient was undergoing bilateral ureteroscopies due to ureteral stones.Flexible ureteroscope placed into the left ureter.Laser was used to bust up the stones.As procedure continued, physician tried to pull the scope back.He met resistance and felt like the scope was stuck.Retraction techniques utilized/attempted.Rigid cystoscope utilized.Upon inspection, the outside lining of the flexible scope was very loose and was bunching.

• Brand Name: URETERO-RENO-FIBERSCOPE FLEX-X²
• 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: 9852990
• MDR Text Key: 184082452
• Report Number: 9852990
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2020

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: Health Professional
• Device Model Number: FLEX-X2S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 106