OLYMPUS SIGMOIDOSCOPE CLV 160 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-02 for OLYMPUS SIGMOIDOSCOPE CLV 160 * manufactured by Olympus America.

Event Text Entries

[402939] This event was previously reported to olympus america. Sigmoidoscope inserted into patient's rectum for procedure. Pt reported that the scope was hot. Scope was withdrawn. Physician verified through touch that the scope was hot. Sent to repair vendor for eval.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1037907
• MDR Report Key: 680279
• Date Received: 2006-02-21
• Date of Report: 2006-01-13
• Date of Event: 2005-05-23
• Date Added to Maude: 2006-03-02
• 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
• Reporter Occupation: RISK MANAGER
• 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: OLYMPUS SIGMOIDOSCOPE
• Generic Name: *
• Product Code: FAM
• Date Received: 2006-02-02
• Returned To Mfg: 2005-05-27
• Model Number: CLV 160
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 669545
• Manufacturer: OLYMPUS AMERICA
• Manufacturer Address: 24001 RINGWOOD AVE SAN JOSE CA 95131 US

Device Sequence Number: 2

• Brand Name: OLYMPUS SIGMOIDOSCOPE
• Generic Name: *
• Product Code: FWM
• Date Received: 2006-02-02
• Returned To Mfg: 2005-05-27
• Model Number: CF-Q1605
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 669604
• Manufacturer: OLYMPUS AMERICA
• Manufacturer Address: 2400 RINGWOOD AVE SAN JOSE CA 95131 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-02-21