STO27050G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2012-05-24 for STO27050G manufactured by Sterilmed, Inc..

Event Text Entries

[2643221] It was reported that during a surgery, the cutting loop of an endoscopic electrode broke into pieces. The broken piece was retrieved and returned.
Patient Sequence No: 1, Text Type: D, B5

[9870530] Final investigation showed that the cutting loop was broke in two places. The unattached section of the loop had been retrieved and was returned. It was not possible to determine the cause of the break.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2134070-2012-00102
• MDR Report Key: 2591186
• Report Source: 01,05,08
• Date Received: 2012-05-24
• Date of Report: 2011-11-22
• Date Mfgr Received: 2011-11-22
• Device Manufacturer Date: 2011-10-01
• Date Added to Maude: 2012-09-28
• 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: TRICIA SCHRATER
• Manufacturer Street: 11400 73RD AVE. NORTH
• Manufacturer City: MAPLE GROVE MN 55369
• Manufacturer Country: US
• Manufacturer Postal: 55369
• Manufacturer Phone: 7634883211
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NA
• Generic Name: ENDOSCOPIC ELECTRODE (NLW)
• Product Code: NLW
• Date Received: 2012-05-24
• Returned To Mfg: 2011-11-28
• Model Number: STO27050G
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STERILMED, INC.
• Manufacturer Address: MAPLE GROVE MN US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-05-24