MAUDE Adverse Event Report: CASE MEDICAL INC. CASE MEDICAL; WRAP, STERILIZATION

Model Number	KSZ-39301BS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Cysto scopes filter container: the device that locks the filter in place does not click as they are supposed to.

• Brand Name: CASE MEDICAL
• Common Device Name: WRAP, STERILIZATION
• Manufacturer (Section D): CASE MEDICAL INC.; 50 west st; bloomfield NJ 07003
• MDR Report Key: 12845545
• Report Number: 12845545
• Device Sequence Number: 19857072
• Product Code: FRG
• UDI-Device Identifier: 00653159007569
• UDI-Public: (01)00653159007569
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/28/2021
• Report Date (Section F): 10/28/2021

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 Model Number: KSZ-39301BS
• Device Catalogue Number: KSZ-39301BS
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/28/2021