OLYMPUS * 83A2183

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-23 for OLYMPUS * 83A2183 manufactured by Olympus America.

Event Text Entries

[121111] Pt. Had hysteroscopy surgery 11/10/1997. On 7/15/1998 pt returned for x-rays. Where a piece of metal appears to be in fallopian tube. Metal is shaped like cutting loop electrode used in surgery on 11/10/1997.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 178868
• MDR Report Key: 178868
• Date Received: 1998-07-23
• Date of Report: 1998-07-21
• Date of Event: 1997-11-10
• Date Facility Aware: 1998-07-21
• Report Date: 1998-07-21
• Date Reported to FDA: 1998-07-22
• Date Reported to Mfgr: 1998-07-22
• Date Added to Maude: 1998-07-28
• Event Key: 0
• Report Source Code: User Facility 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OLYMPUS
• Generic Name: CUTTING LOOP ELECTRODE
• Product Code: HIM
• Date Received: 1998-07-23
• Model Number: *
• Catalog Number: 83A2183
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 173919
• Manufacturer: OLYMPUS AMERICA
• Manufacturer Address: TWO CORPORATE CENTER DR MELVILLE NY 11747 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-07-23