MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; ENDOSCOPIC CONTAMINATION PREVENTION SHEATH

Model Number 27050BE

Device Problem Fracture (1260)

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

Event Date 01/04/2019

Event Type  malfunction  

Event Description

The patient underwent cystourethroscopy with fulguration about 4 months ago.During the visual inspection, the outer sheath of the 22 fr obturator was discovered to be fractured, leaving the tip in the proximal urethra.A new scope was obtained and the fragment was removed without further complication.

• Brand Name: N.A.
• Type of Device: ENDOSCOPIC CONTAMINATION PREVENTION SHEATH
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 8477516
• MDR Text Key: 140737769
• Report Number: 8477516
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2019,02/13/2019

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: No Information
• Device Model Number: 27050BE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2019
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 85