ACMI *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-16 for ACMI * manufactured by Circon.

Event Text Entries

[15617631] While using a # 6 cannula during a d & e the uterus was perforated. Perforated area cauterized with bovie. Pt "doing well" per f/u report on 5/13/98.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 172923
• MDR Report Key: 172923
• Date Received: 1998-06-16
• Date of Report: 1998-05-15
• Date of Event: 1998-05-12
• Date Facility Aware: 1998-05-12
• Report Date: 1998-05-15
• Date Reported to Mfgr: 1998-05-15
• Date Added to Maude: 1998-06-19
• 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
• Reporter Occupation: RISK MANAGER
• 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: ACMI
• Generic Name: D&E CANNULA
• Product Code: HHK
• Date Received: 1998-06-16
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: #6 IMPRINTED ON CANNULA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 168141
• Manufacturer: CIRCON
• Manufacturer Address: 3037 MT. PLEASANT ST. RACINE WI 53404 US
• Baseline Brand Name: BERKELEY VACURETTE CANNULA, F-TIP
• Baseline Generic Name: FLEXIBLE TIP CURETTE
• Baseline Model No: NA
• Baseline Catalog No: 21665
• Baseline ID: F-TIP VACURETTE
• Baseline Device Family: F-TIP VACURETTE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1998-06-16