MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM

Model Number 11272CUK1

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

Product evaluation confirmed that the ocular has a stain.The ifu has statements regarding inspection, checks of the objective lens and eyepiece and water quality recommendations.Root cause of the white film on the eyepiece is user error - improper cleaning and use of sterilization equipment.

Event Description

Per the customer: a white residue around the eyepiece is causing issues with the physician's eyes.On (b)(6) 2018, the physician had experienced irritation and swelling in her eyelids after using this scope in cases.The physician sought medical attention and is using a cream on her eyelids.The physician is doing fine.They forgot to rinse the eyepiece, and issue occurred on (b)(6) 2018 as well with the same doctor and with use of this same scope.Physician indicated that when they rinsed the eyepiece off, there were no issues with the scope.The hospital spd reprocesses their flexible scopes using sterrad.This report is for the first case on (b)(6) 2018.

• Brand Name: FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM
• Type of Device: FLEXIBLE CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14307072
• MDR Text Key: 293732812
• Report Number: 1221826-2022-00064
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K945185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2022

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: 11272CUK1
• Device Catalogue Number: 11272CUK1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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): Required Intervention
• Patient Sex: Female