AIDA HD CONNECT 20205620

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for AIDA HD CONNECT 20205620 manufactured by Karl Storz Gmbh & Co. Kg.

Event Text Entries

[177592516] While specialty care was switching modes, the aida machine shut down making picture-taking capability not available. Specialty care tech restarted machine with no luck of it turning back on. Second tower was brought in. This aida machine froze during cystoscopy, also making picture-taking capabilities unavailable. Surgeon did not lose visualization and patient was not affected, but case was prolonged due to faulty equipment. Original aida was once more turned on and off, and eventually started working.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9664268
• MDR Report Key: 9664268
• Date Received: 2020-02-04
• Date of Report: 2020-01-31
• Date of Event: 2019-12-09
• Report Date: 2020-01-31
• Date Reported to FDA: 2020-01-31
• Date Reported to Mfgr: 2020-02-04
• Date Added to Maude: 2020-02-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AIDA HD CONNECT
• Generic Name: ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY
• Product Code: FET
• Date Received: 2020-02-04
• Model Number: 20205620
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ GMBH & CO. KG
• Manufacturer Address: 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-04