MAUDE Adverse Event Report: ACQUIRE MED LLC. Q LOOP; POWERED LASER SURGICAL INSTRUMENT

Catalog Number Q-MLP-ESO

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2020

Event Type  malfunction  

Event Description

During surgery, the qloop medium cutting loop electrode was used and the surgeon noticed that the loop was not heating evening across the arc; it was only hot in partial areas.The loop was changed out for another one with the same reference and lot numbers and still did the same thing.It was then changed out for another brand of loop electrode and the loop was hot in all areas.The same non-disposable cord was used with all 3 of these electrodes.

• Brand Name: Q LOOP
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ACQUIRE MED LLC.; 1950 s 900 w ste s9; salt lake city UT 84104
• MDR Report Key: 10553009
• MDR Text Key: 207539749
• Report Number: 10553009
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Q-MLP-ESO
• Device Lot Number: AMDE01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 89