MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. URETHROSCOPE SHEATH; CYSTOURETHROSCOPE

Model Number 27040XB

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2016

Event Type  malfunction  

Event Description

Patient was here for holmium laser enucleation of the prostate (holep) and the ceramic tip of the holep scope came off in the patient's bladder.The tip was retrieved and removed.The holep scope was removed from the field and a new one was brought in to the or and used to finish case.

• Brand Name: URETHROSCOPE SHEATH
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 15 wells street; southbridge MA 01550
• MDR Report Key: 6479731
• MDR Text Key: 72364513
• Report Number: 6479731
• Device Sequence Number: 1
• Product Code: FBO
• 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: 03/31/2017

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: No Information
• Device Model Number: 27040XB
• Device Lot Number: YW 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR