MAUDE Adverse Event Report: KARL STORZ KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH CYSTOURETHROSCOPE

Model Number 27028-CA

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/03/2017

Event Type  Injury  

Event Description

Back end of the 20 french cystoscope fractured off in the patient's bladder.

• Brand Name: KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH CYSTOURETHROSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ; 2151 e grand ave; el segundo CA 90245
• MDR Report Key: 6453137
• MDR Text Key: 71678218
• Report Number: MW5068847
• Device Sequence Number: 1
• Product Code: FBO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27028-CA
• Device Lot Number: UW03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR