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

Model Number 27040XB

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 289976763
• Report Number: 9610617-2022-00031
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551076569
• UDI-Public: 4048551076569
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male