MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINI STRAIGHT FORW. TELESCOPE 0°, 0.8 MM

Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
The following was reported: no image, unable to see through, out of the box failure.No negative impact to patient or user.
Additional Manufacturer Narrative
New information received from the customer march 27,.2025.The customer reported that the scope arrived damaged inside the set case, with no vision.Since it is now confirmed that this was an out of the box/damaged upon receipt failure and there was not risk of using the product during a procedure, reportability decision is updated.According to the event description there is no information that the event caused a harm or serious injury to patient, user or third.Since the risk analysis is based to patient, user or third party.In conclusion this is not a reportable event.This event is filed under internal complaint id (b)(4).

• Brand Name: MINI STRAIGHT FORW. TELESCOPE 0°, 0.8 MM
• Common Device Name: MINI STRAIGHT FORW. TELESCOPE 0°, 0.8 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• 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: 21620868
• Report Number: 9610617-2025-00432
• Device Sequence Number: 20961292
• Product Code: GCJ
• UDI-Device Identifier: 04048551051580
• UDI-Public: 04048551051580
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: GCJ
• 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
• Report Date (Section B): 04/01/2025

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
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/01/2025
• 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