MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER TUBE WITH CERAMIC BEAK

Model Number	27050XB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We evaluated the inner tube and found a portion of the ceramic beak is broken off, there are tool marks on the distal end of metal shaft near the beak, and the shaft is dented.In addition, we found that this inner tube has been 3rd party repaired; the ceramic beak is white when it should be gray in color, and the ceramic material is thinner than our gray ceramic material.The most likely cause of this type of breakage of the ceramic beak is mechanical force.
Event or Problem Description
Allegedly, a portion of the inner tube's ceramic beak broke during a turbt procedure; the broken piece was subsequently found in a specimen cup by the lab.

• Brand Name: INNER TUBE WITH CERAMIC BEAK
• Common Device Name: INNER TUBE WITH CERAMIC BEAK
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8745298
• Report Number: 9610617-2019-00053
• Device Sequence Number: 2296694
• Product Code: FBO
• UDI-Device Identifier: 04048551078167
• UDI-Public: 4048551078167
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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
• Operator of Device: Health Professional
• Device Model Number: 27050XB
• Device Catalogue Number: 27050XB
• Device Lot Number: NS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/28/2019
• 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
• Patient Age: 78 YR
• Patient Weight: 104