MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC INSULATION TUBE; RESECTOSCOPE SHEATH, INNER FIXED SHEATH

Model Number	27040XB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ceramic tip fractured/broke from the sheath.The images showed that a ceramic beak was new and shinning and in dark color than the factory original, while the metal sheath looks aged and with dents.We believe the sheath was serviced by a third party, and the beak was replaced with a different ceramic material.
Event or Problem Description
Allegedly, during a urology procedure, the ceramic tip of the sheath broke.The pieces were retrieved, and the procedure was completed.

• Brand Name: INNER CERAMIC INSULATION TUBE
• Common Device Name: RESECTOSCOPE SHEATH, INNER FIXED SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 10870740
• Report Number: 9610617-2020-00128
• Device Sequence Number: 13758126
• Product Code: FBO
• UDI-Device Identifier: 04048551076569
• UDI-Public: 4048551076569
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K943668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27040XB
• Device Catalogue Number: 27040XB
• Device Lot Number: XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention