MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MANIPULATOR ROD

Model Number	26168DZB
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during the procedure, the manipulator rod broke.The procedure was completed with a delay of less than 15 minutes.No one was injured.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the returned article has been inspected.It can be confirmed that the weld seam is broken.This was caused by excessive lateral stress on the rod (e.G.Due to levering, etc.), which led to the breakage.This can be seen from the bent inner guide pin.The above conducted investigations did not reaveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MANIPULATOR ROD
• Common Device Name: MANIPULATOR ROD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21743692
• Report Number: 9610617-2025-00501
• Device Sequence Number: 8734865
• Product Code: HIH
• UDI-Device Identifier: 04048551096192
• UDI-Public: 04048551096192
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K992027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: 26168DZB
• Device Catalogue Number: 26168DZB
• Device Lot Number: YL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 07/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/25/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown