MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,INNER,FIXED.W/CERAMIC; INNER TUBE

Model Number	26055XB
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not responded to our attempts to gather further information and our service technician was informed the customer will not return the product.
Event or Problem Description
The ceramic beak of a sheath broke off while inside a patient.Two broken pieces were retrieved from patient.Second instrument used for observation, no remaining pieces found.No further information is available.
Additional Manufacturer Narrative
The item was evaluated and found the ceramic beak is broken; the shaft is dented; and the stopcock port is rusty.This appears to be maintenance and care.

• Brand Name: TUBE,INNER,FIXED.W/CERAMIC
• Common Device Name: INNER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen ; GM
• MDR Report Key: 10993483
• Report Number: 9610617-2020-00142
• Device Sequence Number: 10938647
• Product Code: HIH
• UDI-Device Identifier: 04048551275573
• UDI-Public: 4048551275573
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 26055XB
• Device Lot Number: PQ01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1