ENDOSCRUB2 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-08 for ENDOSCRUB2 * manufactured by Xomed.

Event Text Entries

[348084] Endo scrub 2 made by xomed appears to be grounding on metal iv pole and running continuously without input from the footpedal control device. The device is supposed to run only when the footpedal is depressed. These 2 machines have been in service for approximately one year and had worked with no problems when they both failed the same way about the same time. A fault in the footpedal was intially suspected but a replacement footpedal had the same problem. These devices are made to be mounted on a metal iv pole. When the machine is taken off the iv pole it runs properly, leading rptr to conclude that there is an "electrical" in the machines which allows grounding to the iv pole. Rptr is concerned that this is a danger to or personnel. Rptr does not think it much of a danger to pts as there is no reason for the pole to contact the pole. Rptr is not an electrician but is concerned about this. No one has been harmed to date by this. These devices are in the operating room at the medical center. It is used to irrigate sinuscopes to clean blood and secretions off.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034591
• MDR Report Key: 571870
• Date Received: 2004-12-08
• Date of Report: 2004-12-08
• Date of Event: 2004-12-08
• Date Added to Maude: 2005-02-11
• 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: 3
• 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 Sequence Number: 1

• Brand Name: ENDOSCRUB2
• Generic Name: *
• Product Code: KAR
• Date Received: 2004-12-08
• Model Number: ENDOSCRUB2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 561737
• Manufacturer: XOMED
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: ENDOSCRUB2
• Generic Name: *
• Product Code: KAR
• Date Received: 2004-12-08
• Model Number: ENDOSCRUB2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 561925
• Manufacturer: XOMED
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-08