STRYKER ENDOSCOPY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-22 for STRYKER ENDOSCOPY * manufactured by Stryker Endoscopy.

Event Text Entries

[18159063] Difficulty visualizing through the lens due to moisture during laparoscopic cholecystotomy which contributed to the need to convert to an open cholecystotomy to control bleeding.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1024151
• MDR Report Key: 378877
• Date Received: 2002-02-22
• Date of Report: 2002-01-30
• Date of Event: 2002-01-21
• Date Added to Maude: 2002-03-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STRYKER ENDOSCOPY
• Generic Name: COUPLER 810 CAMERA
• Product Code: FTS
• Date Received: 2002-02-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 367904
• Manufacturer: STRYKER ENDOSCOPY
• Manufacturer Address: 2590 WALSH AVE SANTA CLARA CA 95051 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2002-02-22