MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPERATING CYSTOSCOPE-URETHROSCOPE

Model Number 27030KAK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Customer reported that two cystoscopes were used in a cystoscopy case.Procedure went routinely without incident.There was no malfunction of the device during the case.Patient developed an infection, but reporter was not sure of the time lapse between the case and the infection onset.Patient returned to the hospital and is currently onsite being monitored.We subsequently learned it was a pseudomonas infection.The patient is still hospitalized but was reported to be doing much better.There were two cystoscopes used for the case, model 27030kak and 27030kbk.This report is for model 27030kak (case #(b)(4)).A separate mdr (case #(b)(4)) will be submitted for model 27030kbk.Additional patient information is not available.

Manufacturer Narrative

The device will be forwarded to the manufacturing site in germany for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

Manufacturer Narrative

Received an update report from health department indicated there was no growth of p.Aeruginosa.Please refer to the attached report.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The reported device was returned for evaluation.Visual and physical inspection were performed.The optics were examined in detail and damage was found at the distal end.In the distal area, there are missing parts of the light guides.There are also notches and impacts in the distal edge area of the optic.The color ring is no longer present.In general, the optic is in good condition.The optic was microbiologically sampled by the u.S.Department of health due to the infection that unfortunately led to the patient's death.No microbiological contamination was detected.Product history was also reviewed and found no deviation.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: OPERATING CYSTOSCOPE-URETHROSCOPE
• Type of Device: 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 ; 4242188247
• MDR Report Key: 16502591
• MDR Text Key: 310879019
• Report Number: 9610617-2023-00050
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551372746
• UDI-Public: 4048551372746
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

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: 27030KAK
• Device Catalogue Number: 27030KAK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 12/29/2023; 02/22/2024
• Supplement Dates FDA Received: 01/25/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Other