GASTROSCOPE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-27 for GASTROSCOPE * manufactured by Olympus America Inc..

Event Text Entries

[21960819] There has been an increasing occurrence of "peeling" of the outer sheath on the insertion tube of these endoscopes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1013386
• MDR Report Key: 159997
• Date Received: 1998-03-27
• Date of Report: 1998-03-17
• Date of Event: 1998-03-16
• Date Added to Maude: 1998-04-01
• 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
• 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: GASTROSCOPE
• Generic Name: GASTROSCOPE
• Product Code: FDS
• Date Received: 1998-03-27
• 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: 155823
• Manufacturer: OLYMPUS AMERICA INC.
• Manufacturer Address: TWO CORPORATE CTR. DR. MELVILLE NY 117473157 US

Device Sequence Number: 2

• Brand Name: SIGMOIDOSCOPE
• Generic Name: SIGMOIDOSCOPE
• Product Code: FAM
• Date Received: 1998-03-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 155825
• Manufacturer: OLYMPUS AMERICA INC.
• Manufacturer Address: TWO CORPORATE CTR. DR. MELVILLE NY 117473157 US

Device Sequence Number: 3

• Brand Name: COLONSCOPE
• Generic Name: COLONSCOPE
• Product Code: FDF
• Date Received: 1998-03-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 155826
• Manufacturer: OLYMPUS AMERICA INC.
• Manufacturer Address: TWO CORPORATE CTR. DR. MELVILLE NY 117473157 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-03-27