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

Model Number 26105BA

Device Problems Poor Quality Image (1408); Optical Distortion (3000)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Event 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.

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).

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).

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
• Type of Device: 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
• MDR Text Key: 322746995
• Report Number: 9610617-2023-00231
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04048551093597
• UDI-Public: 4048551093597
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1