ACUFEX 012036 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-27 for ACUFEX 012036 * manufactured by Acufex S&n Endo.

Event Text Entries

[400125] During an arthroscopic knec surgery, a piece of the arthroscopic scissor punch broke off. The surgeon was able to retrieve the broken piece.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 617192
• MDR Report Key: 617192
• Date Received: 2005-06-27
• Date of Report: 2005-06-13
• Date of Event: 2005-06-10
• Date Facility Aware: 2005-06-13
• Report Date: 2005-06-14
• Date Reported to FDA: 2005-06-14
• Date Reported to Mfgr: 2005-06-14
• Date Added to Maude: 2005-06-28
• 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: 3
• 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: ACUFEX
• Generic Name: ARTHROSCOPIC SCISSOR PUNCH
• Product Code: HRR
• Date Received: 2005-06-27
• Model Number: 012036
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 606894
• Manufacturer: ACUFEX S&N ENDO
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-06-27