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

Model Number	33300
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	05/21/2025
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
It was reported that the forceps broke during a laparoscopic procedure.The metal flap that was lost in the patient's abdomen was located immediately.However, further radiological examinations were necessary to locate the metal fragments, which exposed the patient to x-rays and extended his general anaesthesia by at least two hours.This delayed the end of the operation and subsequent operations.As x-rays were taken and further anaesthesia was administered, the case is deemed reportable.
Additional Manufacturer Narrative
Additional information: because the product was not returned to karl storz tuttlingen for evaluation, it was not possible to carry out a technical inspection.Based on the information available, the breakage of the johan pliers was most likely caused by material fatigue due to age and repeated processing cycles or by improper handling, such as the application of excessive force.Since the product was not available for examination, the exact cause cannot be confirmed.According to the ifu visual as well as functionality should always be checked before every use to avoid injuries and damages to the product.In addition, there is a warning that overloading and exerting to much force can cause the medical device to break, bend or malfunction.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: 22472380
• Report Number: 9610617-2025-01165
• Device Sequence Number: 7853671
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (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