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

Model Number 27030KBK

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 27030kbk (case #971720).A separate mdr (case #971719) will be submitted for model 27030kak.Additional patient information is not available.

• 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
• MDR Report Key: 16507564
• MDR Text Key: 310948353
• Report Number: 2020550-2023-00051
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551372746
• UDI-Public: 4048551372746
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

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: 27030KBK
• Device Catalogue Number: 27030KBK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2023
• Distributor Facility Aware Date: 02/08/2023
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other