MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 36 CM

Model Number	33300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the end of the outer tube broke whilst being used in theatre.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: during the manufacturer's technical inspection, the error description provided by the customer, "broke during procedure", could be confirmed.The bayonet lock at the distal end of the shaft is slightly deformed.This may be due to mechanical impact.The connector at the proximal end is broken.The age of the product (wear/number of reprocessing cycles) may have a negative effect on the material properties.Since the forceps insert is pressed into the shaft and locked in the bayonet and snaps into place around the handle on the proximal side, it is a "closed" system.This ensures that nothing can fall out during use.There is no information on exactly when the damage to the shaft was noticed.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Common Device Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): 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: 22472976
• Report Number: 9610617-2025-01154
• Device Sequence Number: 17180102
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 33300
• Device Catalogue Number: 33300
• Device Lot Number: OU03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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