MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS V. MUELLER; RIGHT ANGLE ELECTRODE WITH SUCTION

Model Number LA8513

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Burn, Thermal (2530)

Event Date 07/16/2020

Event Type  malfunction  

Event Description

It was reported that the tip of the instrument appears to be coming out and tech indicated that it was burning the liver.

• Brand Name: V. MUELLER
• Type of Device: RIGHT ANGLE ELECTRODE WITH SUCTION
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg,
• Manufacturer Contact: jennifer staunton ; 626 cooper ct; schaumburg, ; 9080292
• MDR Report Key: 10440224
• MDR Text Key: 204569774
• Report Number: 1421101-2020-00003
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403054051
• UDI-Public: 10885403054051
• Combination Product (y/n): N
• PMA/PMN Number: K040855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LA8513
• Device Catalogue Number: LA8513
• Device Lot Number: J18VIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 07/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other