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

Model Number 11301BN1

Device Problem Microbial Contamination of Device (2303)

Patient Problem Respiratory Tract Infection (2420)

Event Date 04/04/2019

Event Type  Injury  

Event 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)).

Manufacturer Narrative

The investigation is pending.

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
• Type of Device: 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
• MDR Text Key: 280462770
• Report Number: 9610617-2021-00074
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551226698
• UDI-Public: 4048551226698
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 11301BN1
• Device Catalogue Number: 11301BN1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other