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

Model Number	33300
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
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
According to the information received, it is suspected that a portion of the product may have broken off and may remain within the patient's abdominal cavity.X-rays and ct scans were taken and what appeared to be a part was confirmed, but it is unclear whether it is the broken part of the product in question.
Additional Manufacturer Narrative
Device evaluation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.Based on the picture provided by the customer, the issue described by the customer "product broke off" was confirmed.The picture shows a portion of the bayonet lock at the distal end of the shaft that had broken off.This damage may have resulted from mechanical impact, and the age of the product (normal wear and tear; production date 12/2018) could also have negatively affected the material properties.It is important to note that the pliers insert is designed to be pushed into the shaft, locked in the bayonet mechanism, and secured on the proximal side around the handle, forming a closed system.Therefore, when properly assembled, no component could have become detached or ejected during use.However, a more detailed examination cannot be carried out as no article has been returned.This event is filed under internal 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: 22554013
• Report Number: 9610617-2025-01183
• Device Sequence Number: 13173548
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: Health Professional
• Device Model Number: 33300
• Device Catalogue Number: 33300
• Device Lot Number: RZ04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown