MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RIGID OPTICAL HYSTEROSCOPE; HOPKINS TELESCOPE 30°, 4 MM, 30 CM

Model Number	26105BA
Medical Device Problem Codes	Poor Quality Image (1408); Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had consented to hysteroscopy and tcrf.The scope had been checked before the procedure and the vision was clear even during hysteroscopy.After connecting to bipolar resectoscope the surgeon reported that the vision became foggy and blurry while in the cavity.We changed to another scope which was clear and the surgeon was happy with it.When he inserted it in the patient's uterine cavity the surgeon reported the second scope was also foggy and blurry.As both scopes were not clear the surgeon decided it was not safe to proceed and abandoned the procedure.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.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).
Additional Manufacturer Narrative
The corrected information is provided in section h4 to reflect the accurate manufacture date.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
During the investigation of the concerned scope it was found that the distal solder seam shows mechanical damage resulting in leakage.Exposure of the distal coverslip to cold spray showed that moisture condenses in the closed system (the system is leaking).Heavy abrasion/foreign matter is evident in the rod lens system, suggesting the possible use of ultrasound during reprocessing.The examination of the optics revealed that the customer's information about a sudden visual impairment can be confirmed.Due to the existing mechanical damage of the distal solder seam and the resulting leakage of the system, a rapid change of the ambient temperature (insert into the situs) leads to condensation of existing moisture in the rod lens system, which impairs the vision as described.The existing mechanical damage is due to external influences and not to a production defect.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: RIGID OPTICAL HYSTEROSCOPE
• Common Device Name: HOPKINS TELESCOPE 30°, 4 MM, 30 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: 17691479
• Report Number: 9610617-2023-00231
• Device Sequence Number: 6378645
• Product Code: FAJ
• UDI-Device Identifier: 04048551093597
• UDI-Public: 4048551093597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943176
• 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,Followup
• Report Date (Section B): 11/16/2023

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: 26105BA
• Device Catalogue Number: 26105BA
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/07/2023; 11/13/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/07/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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