MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. CYSTO-URETHRO-FIBERSCOPE; FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE

Model Number 11272C1

Device Problems Contamination (1120); Microbial Contamination of Device (2303)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The event occurred in germany.The customer reports a possible incident due to germs in the instrument.No details regarding malfunction, patient involvement, or negative impact on the state of health were reported.Further information was requested but not received at this time.Thus, in terms of caution, this case is deemed reportable.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The initial case for this report was deemed reportable, but after the evaluation of the product, it has been concluded that there were no issues with the device.The event was re-evaluated and is considered not reportable.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Type of Device: FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245
• Manufacturer (Section G): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 16904841
• MDR Text Key: 314934916
• Report Number: 1221826-2023-00098
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 4048551226100
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K945185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/04/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other