MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TELE-LARYNGOSCOPE 70°, 5.8 MM

Model Number	8700CKA
Medical Device Problem Codes	Optical Problem (3001); Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that there was no image (veterinary surgery).No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the customer's statement "there is no image, it seems to have burned fibers.No image" cannot be confirmed.The optics we have been provided with were opened by a third-party repair service not authorized by karl storz, and imaging components were destroyed.The distal cover glass shows air bubbles in the silicone separating layer, which may have been caused by mechanical impact or by the third-party repair attempt.There are solid foreign particles/glass splinters in the rod lens system.During disassembly of the optics, a manually and improperly performed milling was found on the "end plate" component, the function of which cannot be determined.The built-in prism mirror is cracked/broken.The damage found was caused by unauthorized third-party repairs not authorized by karl storz, destroying the component, and cannot be attributed to a manufacturing/production defect.The 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.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TELE-LARYNGOSCOPE 70°, 5.8 MM
• Common Device Name: TELE-LARYNGOSCOPE 70°, 5.8 MM
• 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: 22701277
• Report Number: 9610617-2025-01345
• Device Sequence Number: 8944787
• Product Code: EOB
• UDI-Device Identifier: 04048551216422
• UDI-Public: 4048551216422
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K945788
• 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
• Report Date (Section B): 12/03/2025

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: 8700CKA
• Device Catalogue Number: 8700CKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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