MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INTUBATION FIBERSCOPE; FLEXIBLE FIBER OPTIC INTUBATION LARYNGOSCOPE

Model Number	11301BN1
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): the affected fiberscope was used for the treatment of 2 patients.Both patients were infected with a bacterium called pseudomonas aeruginosa, but no serious deterioration in state of health was reported.This report represents the event for patient 2 of 2.(mfr's.Internal complaint # (b)(4)).
Additional Manufacturer Narrative
The investigation is pending.
Additional Manufacturer Narrative
The device was sent to an external laboratory.According to the investigation report, the bacterium called pseudomonas aeruginosa could be found inside the unit.After applying a highlevel cleaning/disinfection procedure, the examination performed showed that no revivable microorganisms could be detected in the channels.Further sampling after a high level maintenance followed by a 24-hour storage maintenance procedure, followed by a 24-hour storage period, revealed no evidence of of any detectable viable microorganisms were present according to the methods used.Based on these results, it was determined that the microbiological quality of the storz endoscope 11301bn1 n°2249439 is satisfactory.As well as the target value (< 1 cfu (colony-forming unit) / endoscope), which is defined in the instruction no.Dgos/pf2/dgs/vss1/2016/220 dated july 4, 2016, corresponds to the target value (< 1 cfu/endoscope) for an endoscope that has been subjected to high-level disinfection and rinsed with sterile water.Based on these results, the most probable root cause is a reprocessing error.The customer will be informed about the reprocessing issue.

• Brand Name: INTUBATION FIBERSCOPE
• Common Device Name: FLEXIBLE FIBER OPTIC INTUBATION LARYNGOSCOPE
• 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: 12770871
• Report Number: 9610617-2021-00074
• Device Sequence Number: 3145113
• Product Code: CAL
• UDI-Device Identifier: 04048551226698
• UDI-Public: 4048551226698
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11301BN1
• Device Catalogue Number: 11301BN1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown