MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINIATURE TELESCOPE 0°, 1.2 MM, 20 CM

Model Number	27033AA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were issues with 27033aa / r27033aa (miniature straight forward telescope).The complaint describes a darkened image / black spot.
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The omplaint reported that there was a dark area in the center of the image.The technical evaluation concluded that no problem was found, and the scope appeared to be in work-ing condition.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MINIATURE TELESCOPE 0°, 1.2 MM, 20 CM
• Common Device Name: MINIATURE TELESCOPE
• 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: 17979054
• Report Number: 9610617-2023-00305
• Device Sequence Number: 14076469
• Product Code: FGB
• UDI-Device Identifier: 04048551205044
• UDI-Public: 4048551205044
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K940464
• 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
• Report Date (Section B): 10/20/2023

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: 27033AA
• Device Catalogue Number: 27033AA
• Device Lot Number: 4082678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 10/20/2023
• 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