MAUDE Adverse Event Report: KARL STORZ SE & Co. KG CAMPO TROPHYSCOPE

Model Number	26008BAC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "during a hysteroscopic procedure for vaginal septum resection, the insulation sheath of the fine-tip electrode (ref.(b)(4) melted onto the optic telescope (ref.(b)(4) during use, and the fine tip broke off inside the uterine cavity.Use of the device was immediately discontinued, and the damaged equipment was isolated and identified.An active search was undertaken for the broken tip fragment, which was initially visualized within the uterine cavity mucosa using a 26 ch hystero-resectoscope.Attempts to retrieve the fragment with a hysteroscope and curette were unsuccessful.At the surgeon's request, a bettocchi hysteroscope with a small curette and grasping forceps was then used; however, the fragment could no longer be visualized.An extensive search was conducted both within the uterine cavity and throughout the operating environment, including examination of the resectoscope working channels, suction tubing, neptune suction filter, operating room floor, surgical drapes, blood clots, and recovered tissue specimens.A plain abdominal x-ray (kub/asp) was performed, with no abnormal findings.The broken tip fragment could not be located or recovered.
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).

• Brand Name: CAMPO TROPHYSCOPE
• Common Device Name: CAMPO TROPHYSCOPE
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 50242718
• Report Number: 50242718
• Device Sequence Number: 10267865
• Product Code: HIH
• UDI-Device Identifier: 04048551276006
• UDI-Public: 04048551276006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026
• Report Date (Section F): 08/13/2026

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: 26008BAC
• Device Catalogue Number: 26008BAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 08/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown