MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER CERAMIC TUBE; 8MM FIXED INNER TUBE

Model Number	26040XA
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken beak was not returned with the device.There is black residue at the spot of breakage on shaft, in addition the proximal end is gouged.
Event or Problem Description
During a procedure the ceramic tip fractured.The piece was able to retrieved.No harm to patient was reported.
Additional Manufacturer Narrative
During a procedure, the ceramic tip broke off.The piece could be recovered this lot was most likely specified incorrectly by the customer, only lot no02 could be found in the based on our initial investigation, the product history did not show any deviation and the product passed the final inspection.Also, by reviewing the similar complaint and product history data, there is no indication for an increase/ trend of the reported issue.Based on further review the report findings noted the root cause is most probably cause is a user error.The piece could be recovered.The ifu points out that the ceramic tip of the shaft should be checked for damage etc.And that care should be taken when handling the ceramic tip.Take care when handling the ceramic tip, otherwise it may break during use.

• Brand Name: INNER CERAMIC TUBE
• Common Device Name: 8MM FIXED INNER TUBE
• 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: 15327756
• Report Number: 9610617-2022-00256
• Device Sequence Number: 5375280
• Product Code: HIH
• UDI-Device Identifier: 04048551092057
• UDI-Public: 4048551092057
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 26040XA
• Device Catalogue Number: 26040XA
• Device Lot Number: NO22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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: Unknown