MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°

Model Number	27293AA
Medical Device Problem Codes	Chemical Problem (2893); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that vision was lost during a surgery.The intervention was delayed 45 minutes.The patient didn't suffer any harm, and the surgery was finished accordingly.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
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
Device evaluation: the complained 27293aa was received on 2025-03-26 at the manufacturing site and was therefore available for investigation.The investigation has been completed on july 3.2025 during the examination, a leak in the distal solder seam due to chemical attack was detected.Moisture was found in the rod lens system.Furthermore, foreign particles are visible in the rod lens system.Additionally, the distal end shows an impact mark in the edge area.The customer's statement regarding "the vision was lost" cannot be confirmed.The imaging in the sharp area is blurred at the right edge but clear in the rest of the imaging.In the blurred area, residues/intruded moisture can be detected, which may affect the image quality.The distal solder joint is chemically attacked and leaking, which can facilitate the intrusion of moisture.Furthermore, an impact mark can be seen at the distal end, which can be partly responsible for the foreign particles present.The ocular bridge shows a scratch or abrasion mark, possibly caused by a holding device.The detected damages are not due to a manufacturing/production error and were most likely caused by clinical application/clinical reprocessing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 6°
• Common Device Name: HOPKINS TELESCOPE 6°
• 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: 21649190
• Report Number: 9610617-2025-00472
• Device Sequence Number: 12646407
• Product Code: FGA
• UDI-Device Identifier: 04048551233795
• UDI-Public: 04048551233795
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K232370
• 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,Followup,Followup
• Report Date (Section B): 07/17/2025

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: 27293AA
• Device Catalogue Number: 27293AA
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 03/26/2025; 07/03/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/22/2025; 04/22/2025; 07/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown