MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number F2/8TA23S

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Information (3190)

Event Date 05/14/2015

Event Type  No Answer Provided  

Event Description

Upon receipt, we noticed the peel packs were openand the internal vials were opened.We deemed the products not sterile.

• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 4855829
• MDR Text Key: 5875111
• Report Number: 4855829
• Device Sequence Number: 1
• Product Code: NLP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/14/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Device Operator: Invalid Data
• Device Catalogue Number: F2/8TA23S
• Device Lot Number: 0209393951
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2015
• Patient Sequence Number: 1