MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTO-URETHRO-FIBERSCOPE; CYSTOURETHROSCOPE

Model Number 11272C1

Device Problems Break (1069); Contamination (1120)

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

Event Date 01/15/2019

Event Type  malfunction  

Event Description

Pre-procedure diagnosis: left staghorn calculus.Procedure name: elective left percutaneous nephrolithotomy, left nephrostomy tube insertion, left nephrostogram.Procedure findings: left renal calculus extracted successfully utilizing flexible nephroscope, left nephrostogram demonstrates no extravasation.Condition: patient tolerated procedure.Disposition: transferred to: pacu.Surgeon observed black particle when doing procedure - realized it came from end of flexible cystoscope - was able to retrieve it and the piece matched the end of the cystoscope - model#11272 c1 - manufacturer is storz.Instrument had broken pieces of coating on tip of scope.The scrub tech, surgeon and rn in case examined the scope tip and decided that all pieces had been retrieved.Patient stable and discharged home.Scope going for repair.

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; 2151 e grand avenue; el segundo CA 90245
• MDR Report Key: 8939302
• MDR Text Key: 155809446
• Report Number: 8939302
• Device Sequence Number: 1
• Product Code: FBO
• 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: 08/21/2019

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: Other
• Device Model Number: 11272C1
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA