MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG STORZ CYSTOSCOPE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

During a cystoscopy with clot evacuation and fulguration, the inner sheath of the cystoscope reportedly broke off in the patient's penis.Staff reported all pieces were removed.No patient harm noted related to the event.

• Brand Name: STORZ CYSTOSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand ave; el segundo CA 90245
• MDR Report Key: 17049551
• MDR Text Key: 316419693
• Report Number: 17049551
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2023

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male