MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINI STRAIGHT FORWARD TELESCOPE 0°,1.1MM

Model Number	11573A
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the optic was foggy.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.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
Correction made to section d4.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the analysis of the causes of the optics, a break in the image guide was detected, which negatively affects the image quality.The customer's information can therefore be confirmed.It was determined that the image guides were mechanically damaged.The damage is not due to a manufacturing/production defect.It is possible that the image guides were mechanically damaged during clinical use/clinical reprocessing.In the ifu v5.0 - 11/2017 96126012d for the optics, we expressly point out the correct handling and reprocessing due to the delicacy and sensitivity of the product to prevent damage to the optics and its individual components.No further measures will be taken.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.This event is filed under internal complaint id (b)(4).

• Brand Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.1MM
• Common Device Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.1MM
• 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: 22070996
• Report Number: 9610617-2025-00907
• Device Sequence Number: 18466923
• Product Code: GCJ
• UDI-Device Identifier: 04048551051597
• UDI-Public: 04048551051597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K012527
• 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): 09/26/2025

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: 11573A
• Device Catalogue Number: 11573A
• Device Lot Number: 4093377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided; 09/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/03/2025; 09/26/2025
• 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