DISSECTOR, SJ AR-7300DS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-21 for DISSECTOR, SJ AR-7300DS manufactured by Arthrex, Inc..

Event Text Entries

[83127463]
Patient Sequence No: 1, Text Type: N, H10

[83127464] During case, tip from dissector broke off. Dr. Retrieved from surgical area.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6806760
• MDR Report Key: 6806760
• Date Received: 2017-08-21
• Date of Report: 2017-08-02
• Date of Event: 2016-07-06
• Report Date: 2016-07-06
• Date Reported to FDA: 2016-07-06
• Date Reported to Mfgr: 2016-07-06
• Date Added to Maude: 2017-08-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: DISSECTOR, SJ
• Generic Name: INSTRUMENT, SURGICAL, ORTHOPEDIC,ARTHROSCOPIC
• Product Code: NBH
• Date Received: 2017-08-21
• Model Number: AR-7300DS
• Catalog Number: AR-7300DS
• Lot Number: 10038635
• Operator: PHYSICIAN
• Device Availability: *
• Device Age: 6 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: ARTHREX, INC.
• Manufacturer Address: 1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108

Device Sequence Number: 1

• Brand Name: DISSECTOR, SJ
• Generic Name: INSTRUMENT, SURGICAL, ORTHOPEDIC,ARTHROSCOPIC
• Product Code: GDI
• Date Received: 2017-08-21
• Model Number: AR-7300DS
• Catalog Number: AR-7300DS
• Lot Number: 10038635
• Operator: PHYSICIAN
• Device Availability: *
• Device Age: 6 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARTHREX, INC.
• Manufacturer Address: 1370 CREEKSIDE BLVD NAPLES FL 34108 US 34108

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-08-21