MAUDE Adverse Event Report: OSTA CUTTING LOOP (12/PK)

Model Number MLE-28-012

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.No device returned.

Event Description

During a turp procedure not long after the start of the procedure the loop appeared to be "burnt out" and the wire broke right at the center/apex of the curve on the loop.As this procedure is performed under direct vision, the surgeon was able to immediately stop the procedure and the broken electrode was switched for another from the same box.The same fault then occurred with the 2nd electrode.This electrode was then switched for an electrode from a new box (with a different lot number) and there were no further problems.The procedure was completed normally with no detrimental effects on the patient.

Manufacturer Narrative

Six unopened electrodes were returned, lot 789563jf.Two electrodes were tested on steak tissue, connected to a valley lab force ii generator set at pure cut 20.The tissue was placed onto a grounding pad, the generator was activated and the cut function applied.Both devices cut the sample tissue, no burn out or loop breakage observed.Could not confirm the customers complaint.No information was provided as to the generator power setting.

• Brand Name: CUTTING LOOP (12/PK)
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: terrence sullivan ; 136 turnpike road; southborough, MA 01772 ; 508804-273
• MDR Report Key: 5955607
• MDR Text Key: 55268794
• Report Number: 3011050570-2016-00008
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-28-012
• Device Lot Number: 789563JF
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1