MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA. INC HOPKINS TELESCOPE 70°, 4 MM

Model Number	27005CA
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Improper Chemical Reaction (2952); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint (b)(4).
Event or Problem Description
It was reported that vision was not clear.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correction in section d9 product was returned on 05/29/2025.This event is filed under internal complaint id_(b)(4).
Additional Manufacturer Narrative
During the examination of the optics, a chemically damaged solder seam was found.There are adhering residues/deposits on the distal cover glass, which negatively affect the imaging.The customer's statement can be confirmed.During the examination of the optics, it was determined that the solder seam was significantly damaged by chemicals.There are adhering residues/deposits on the distal cover glass that impair imaging.Furthermore, residues/abrasion can be detected in the rod lens system, which may have slipped into the field of view of the individual rod lens sections during clinical use.The foreign particles have no influence on the sharpness of the optics.The defects found are not due to a manufacturing/production error.The mechanical abrasion may have been caused by clinical use.The chemical damage was caused by improper clinical reprocessing soaking time, chemicals, exposure time.This event is filed under internal complaint id_ (b)(4).

• Brand Name: HOPKINS TELESCOPE 70°, 4 MM
• Common Device Name: HOPKINS TELESCOPE 70°, 4 MM
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA. INC; 2151 e. grand avenue; el segundo CA 90245
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22101695
• Report Number: 9610617-2025-00940
• Device Sequence Number: 12581909
• Product Code: FAJ
• UDI-Device Identifier: 04048551001073
• UDI-Public: 04048551001073
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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
• Device Model Number: 27005CA
• Device Catalogue Number: 27005CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 10/15/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 05/30/2025; 10/29/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown