MAUDE Adverse Event Report: ACMI RIGHT ANGLE CUTTING LOOP ELECTRODE 0.012 WIRE, 26FR; RT ANGLE CUTTING LOOP ELECTRODE

Model Number MLE-26-012

Device Problems Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2016

Event Type  malfunction  

Event Description

Acmi right angle cutting loop electrode (0.012 wire, 26 fr.) removed from package and surgeon noticed there was an extra metal piece on the non-working end of the device (which is not normally there).Causing the electrode to not be placed into the resectoscope properly.Device not used on pt.

• Brand Name: RIGHT ANGLE CUTTING LOOP ELECTRODE 0.012 WIRE, 26FR
• Type of Device: RT ANGLE CUTTING LOOP ELECTRODE
• Manufacturer (Section D): ACMI; duluth CA 30096
• MDR Report Key: 5920439
• MDR Text Key: 53907552
• Report Number: MW5064472
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Model Number: MLE-26-012
• Device Catalogue Number: MLE-26-012
• Device Lot Number: 772883GF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR