MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW

Model Number	11272VH
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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).
Event or Problem Description
It was reported "electronic no image".Currently there is no information that the event caused a harm or serious injury to a patient, user or third.
Additional Manufacturer Narrative
Additional information is provided in section b5 and h6.Correction: the initial mdr was submitted with the wrong manufacturing year of 2024.The correct manufaturing year for this event is 2025.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Further information was received on 13-mar-2025.Regarding the reported error it was stated electronic no image - loose contact.The cystoscope has a defect (possible tear) on the shaft (where the flexible part begins).It was also confirmed that the defect was already detected in the morning during preparations and not during use on a patient.Further it was stated that the planned examination (cystoscopy) had to be postponed from the original planned date (b)(6) 2025) for 13 days (a replacement device was already received on (b)(6) 2025 but there was no earlier time slot available for the examination).The patient did not have to be hospitalized during this time and came back to the doctor's office on the rescheduled appointment.It was confirmed that the procedure was successfully completed on the rescheduled date and there were no adverse consequences for the patient.
Additional Manufacturer Narrative
Result of investigation: a visual and functional test was carried out on the returned endoscope.The endoscope shows signs of use such as scratches and discoloration on the handle, housing, channel inlets and chemical stains from reprocessing.The contacts of the ccu supply plug are damaged and the angulation is out of tolerance.The interface board is defective (corroded).The causes of these problems are due to usage errors or/and wear.The image is according to specification.The image quality was inspected using image s x-link sn (b)(6) and image 1s (b)(6) and the endoscope is airtight, no leakage.The error described by the customer "no image" could not be confirmed during inspection.It is very likely that the picture failure described by the customer is due to moisture in the housing, which also caused the interface board to corrode.After the moisture had evaporated after some time, the image worked again.The endoscope was not leaking, and moisture can only enter the sealed instrument via the pressure equalization valve.For this reason, a user error is to be assumed which led to the missing image.The conducted investigations did not reveal a root cause related to the labelling, the device or its history.Correction: the initial mdr was submitted with the wrong manufacturing year of 2024.The correct manufaturing year for this event is 2025.Internal karl storz reference number: (b)(4).

• Brand Name: FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW
• Common Device Name: FLEXIBLE VIDEO CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21470483
• Report Number: 1221826-2024-00322
• Device Sequence Number: 3652534
• Product Code: FAJ
• UDI-Device Identifier: 04048551423226
• UDI-Public: 04048551423226
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K191357
• 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): 09/24/2025

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: 11272VH
• Device Catalogue Number: 11272VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 09/11/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/28/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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