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

Model Number 27033AA

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The unit in question was requested for return.The investigation is anticipated, but not yet begun.

Event 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)).

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
• Type of Device: 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
• MDR Text Key: 277899682
• Report Number: 9610617-2021-00070
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551205044
• UDI-Public: 4048551205044
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K940464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27033AA
• Device Catalogue Number: 27033AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other