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

Model Number	27040XB
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ceramic tip fractured/broke from the sheath at end of procedure when pulling out instrument.A missing piece is still in patient.The sheath is over 8 years old.
Event or Problem Description
During a turp, surgeon completed the surgery, and realized when pulling out the instruments that a broken piece of ceramic came out.A missing piece is still in the patient.
Additional Manufacturer Narrative
An investigation report from kst/mfr.Was received which states: the conclusion and root cause of the non-return product: "the most likely cause is the age ( 8 years) of the item and the high" application cycles.This probably caused micro cracks on the ceramic beak, which led to the breakage of the beak during extraction.

• 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, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14084349
• Report Number: 9610617-2022-00031
• Device Sequence Number: 5289310
• Product Code: FBO
• UDI-Device Identifier: 04048551076569
• UDI-Public: 4048551076569
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27040XB
• Device Catalogue Number: 27040XB
• Device Lot Number: NV01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male