30 HYSTEROSCOPE * A469 4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-08 for 30 HYSTEROSCOPE * A469 4 manufactured by Olympus America, Inc..

Event Text Entries

[135410] Procedure - hysteroscopy. Flakes of metal seen during hysteroscopy. All observed flakes removed from uterus by physician during procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017144
• MDR Report Key: 239741
• Date Received: 1999-09-08
• Date of Report: 1999-09-08
• Date of Event: 1999-07-17
• Date Added to Maude: 1999-09-15
• 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: 30 HYSTEROSCOPE
• Generic Name: BX FORCEP
• Product Code: HFB
• Date Received: 1999-09-08
• Model Number: *
• Catalog Number: A469 4
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 232301
• Manufacturer: OLYMPUS AMERICA, INC.
• Manufacturer Address: 2 CORPORATE CENTER DR. MELVILLE NY 117473157 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-09-08