MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINI STRAIGHT FORWARD TELESCOPE 0°,1.6MM

Model Number	11583A
Medical Device Problem Codes	Optical Problem (3001); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference case id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported regarding two scopes: when physician went to use the scope, he was doing a check to see if the light and focus were optimal, he noticed the fibers and picture quality were poor and was unable to use the scope.The physician had to cancel the procedure.Cross reference mdr: 9610617-2024-00474.
Additional Manufacturer Narrative
Additional information: the devices were not sent to the karl storz assessment and repair department for inspection, the error description provided by the customer, "fibers and picture quality were poor" could not be confirmed.The items mentioned in this report cannot be examined because, the customer has not provided us with the items for further cause analysis.Possible causes of failure are speculative now.If the items are used in a manner that deviates from their intended area of application, purpose, or if they are subjected to excessive strain or incorrect reconditioning, products may be damaged or destroyed.If the items mentioned are nevertheless sent to us, the report will be reopened, and a cause analysis will be carried out.The investigations did not reveal a root cause related to the labelling, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's 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.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.6MM
• Common Device Name: MINI STRAIGHT FORWARD TELESCOPE 0°,1.6MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20782544
• Report Number: 9610617-2024-00473
• Device Sequence Number: 17406415
• Product Code: GCJ
• UDI-Device Identifier: 04048551006283
• UDI-Public: 04048551006283
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 11583A
• Device Catalogue Number: 11583A
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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