MIC1333

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-05-24 for MIC1333 manufactured by Sterilmed, Inc..

Event Text Entries

[16627249] Final investigation showed that the jaws were able to open and close, and that the device operated as designed. There was a kink on the forceps which did not impair the device's ability to function.
Patient Sequence No: 1, Text Type: N, H10

[16675724] It was reported that during a procedure, the jaws of a biopsy forceps were stuck in a closed position.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2134070-2012-00090
• MDR Report Key: 2591231
• Report Source: 05,07
• Date Received: 2012-05-24
• Date of Report: 2011-10-05
• Date Mfgr Received: 2011-10-05
• Device Manufacturer Date: 2011-07-01
• Date Added to Maude: 2012-06-05
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: COLD BIOPSY FORCEPS (NON)
• Product Code: NON
• Date Received: 2012-05-24
• Returned To Mfg: 2011-10-11
• Model Number: MIC1333
• 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