* OHS-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-03 for * OHS-1 manufactured by Leica Biosystems Imaging, Inc.

Event Text Entries

[4553214] Scope would not focus. Patient was on the table, exposed, the surgical team was ready for the scope and it would not focus.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3763207
• MDR Report Key: 3763207
• Date Received: 2014-04-03
• Date of Report: 2014-04-03
• Date of Event: 2014-03-17
• Report Date: 2014-04-03
• Date Reported to FDA: 2014-04-03
• Date Reported to Mfgr: 2014-04-22
• Date Added to Maude: 2014-04-22
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: MICROSCOPE
• Product Code: NOT
• Date Received: 2014-04-03
• Model Number: OHS-1
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 10 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LEICA BIOSYSTEMS IMAGING, INC
• Manufacturer Address: 1360 PARK CENTER DRIVE VISTA CA 92081 US 92081

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-03