OLYMPUS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-07 for OLYMPUS * manufactured by *.

Event Text Entries

[181442] During a hysterecteroscopy, while attempting to remove an intrauterine device, the jaws of the grasper broke. Half of the jaw was retrieved and half was not. Physician made aware of situation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 285433
• MDR Report Key: 285433
• Date Received: 2000-07-07
• Date of Report: 2000-06-06
• Date of Event: 2000-06-02
• Date Facility Aware: 2000-06-02
• Report Date: 2000-06-06
• Date Added to Maude: 2000-07-14
• 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: GRASPER A4695
• Product Code: HCZ
• Date Received: 2000-07-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 276222
• Manufacturer: *
• Manufacturer Address: 2080 SPRINGER DRIVE LOMBARD IL 601488419 US
• Baseline Brand Name: OLYMPUS
• Baseline Generic Name: SEMI RIGID FOREIGN BODY FORCEPS
• Baseline Model No: A4695
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K790071
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-07-07