MAUDE Adverse Event Report: KARL STORZ SE & Co. KG FIVE S 3.5x65, sterile, for single use

Model Number	091361-01
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that image interference and distortion occurred during a procedure (two different scoped from same box).Flexing the tip worsened the image quality and made visualization of the area of interest difficult for the veterinarian.The procedure was prolonged by more than 30 minutes but less than 60 minutes.
Additional Manufacturer Narrative
The device in question has been requested by the manufacturer but has not yet returned for evaluation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FIVE S 3.5x65, sterile, for single use
• Common Device Name: FIVE S 3.5x65, sterile, for single use
• 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: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 50675735
• Report Number: 9610617-2026-02123
• Device Sequence Number: 10429780
• Product Code: CAL
• UDI-Device Identifier: 04048551422533
• UDI-Public: 04048551422533
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 091361-01
• Device Catalogue Number: 091361-01
• Device Lot Number: 500133091
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Material: 091361-01Batch/Lod code: 500133091
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown