MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINIATURE OPTICS 0°, 1.2 MM, 20 CM; FLEXIBLE FIBER OPTIC CYSTOSCOPE

Model Number	27033AA
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit in question was requested for return.The investigation is anticipated, but not yet begun.
Event or Problem Description
As per a manufacturer incident report we received from the factory in germany: it was reported that during patient treatment the quality of view was too low to work with the optics.The procedure had to be abandoned due to a missing replacement unit.(mfr's.Internal complaint #(b)(4)).
Additional Manufacturer Narrative
Upon the evaluation (dated (b)(6) 2021) it could be confirmed that moisture was inside the lens.Moisture was able to penetrate the scope due to mechanical damage to the lens.The most probable root cause is that the lens was damaged due to unanticipated mechanical impact.According to the corresponding instructions for use (mcx620_en_v1.0_ifu_ce-mdr, chapter 3.2), it is written that all components must be checked before each use.The customer will be informed in a separate letter.

• Brand Name: MINIATURE OPTICS 0°, 1.2 MM, 20 CM
• Common Device Name: FLEXIBLE FIBER OPTIC CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12681525
• Report Number: 9610617-2021-00070
• Device Sequence Number: 1364202
• Product Code: FGB
• UDI-Device Identifier: 04048551205044
• UDI-Public: 4048551205044
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown