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

Model Number KSZ-39301BS

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  malfunction  

Event 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
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): CASE MEDICAL INC.; 50 west st; bloomfield NJ 07003
• MDR Report Key: 12845545
• MDR Text Key: 281036555
• Report Number: 12845545
• Device Sequence Number: 1
• Product Code: FRG
• UDI-Device Identifier: 00653159007569
• UDI-Public: (01)00653159007569
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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
• Date Report Sent to FDA: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male