MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 0°, 5MM, 24CM

Model Number	8712AA
Medical Device Problem Codes	Temperature Problem (3022); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Burn(s) (1757); Foreign Body In Patient (2687)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the end of hopkins rod touched the arm of a member of staff causing a small burn to arm.The issue was identified after medical procedure.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to 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.Leading device: 8712aa returned on august 7,2025.Concomitant device: 495na returned on august 7,2025.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: reported issue: hand burnt by distal tip of scope.Investigation: the examination of the optic revealed normal signs of wear on the optics.The rod-lens system shows abrasion attributable to normal clinical use.The inspection of the light cable revealed no damage.The light cable shows normal signs of wear.Conclusion: during the examination of the articles in question, no deviations or damage that could impair their function were found.About the customer's description "hand burnt by distal tip of scope," we expressly point out in the instructions for use ifu96216001d pages 4 + 5, 12 + 13 and ifudsx551_en_v2.1_08-2024_ifu_ce_mdr page 8 + page 9, we expressly advise avoiding direct contact with the light exit port.The customer acted contrary to the safety instructions in the instructions for use, causing a burn to the palm of their hand.This is a case of user error.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.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 0°, 5MM, 24CM
• Common Device Name: HOPKINS TELESCOPE 0°, 5MM, 24CM
• 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: 22755190
• Report Number: 9610617-2025-01398
• Device Sequence Number: 8607018
• Product Code: EOB
• UDI-Device Identifier: 04048551216590
• UDI-Public: 04048551216590
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2026

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: 8712AA
• Device Catalogue Number: 8712AA
• Device Lot Number: 1201QC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 01/12/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/18/2025; 01/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 495NA FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown