SSI SIDE CUTTING FORCEPS 32-119

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-27 for SSI SIDE CUTTING FORCEPS 32-119 manufactured by Symmetry Surgical Inc..

Event Text Entries

[4118713] When newly purchased wire cutters were used under normal circumstances, the cutting edge fractured and broke off.
Patient Sequence No: 1, Text Type: D, B5

[11410283] Possibly cut wire that was too thick or harder then the instrument was designed to cut causing the breakage.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3007208013-2013-00016
• MDR Report Key: 3544734
• Report Source: 07
• Date Received: 2013-11-27
• Date of Report: 2013-11-27
• Date of Event: 2013-10-28
• Date Mfgr Received: 2013-10-31
• Date Added to Maude: 2014-03-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Event Location: 0
• Manufacturer Contact: CHRIS SMITH, DIRECTOR
• Manufacturer Street: 3034 OWEN DR
• Manufacturer City: ANTIOCH TN 37013
• Manufacturer Country: US
• Manufacturer Postal: 37013
• Manufacturer Phone: 8002513000
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SSI SIDE CUTTING FORCEPS
• Generic Name: WIRE CUTTING FORCEPS
• Product Code: GZX
• Date Received: 2013-11-27
• Returned To Mfg: 2013-10-31
• Model Number: 32-119
• Catalog Number: 32-119
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYMMETRY SURGICAL INC.
• Manufacturer Address: ANTIOCH TN 37013 US 37013

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-11-27