MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 43 CM

Model Number	33400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during laparoscopic surgery on the sigmoid colon, the surgeon noticed a malfunction in the johanne multi-purpose grasping forceps, resulting in the detachment of a small metal fragment into the abdomen.The fragment was immediately identified and retrieved without causing any harm to the patient.An abdominal x-ray was performed to rule out the presence of other fragments, with negative results.It should be noted that the instrument was functioning correctly at the start of the procedure.The patient was submitted to additional x-ray check-up not foreseen, with extension of surgical procedure.Since the additional x ray was required, this case is reportable.

• Brand Name: METAL OUTER SHEATH, INSULATED, 43 CM
• Common Device Name: METAL OUTER SHEATH, INSULATED, 43 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: 24708749
• Report Number: 9610617-2026-00666
• Device Sequence Number: 10467267
• Product Code: GCJ
• UDI-Device Identifier: 04048551142707
• UDI-Public: 04048551142707
• 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
• Report Date (Section B): 03/26/2026

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: 33400
• Device Catalogue Number: 33400
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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