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

Model Number	LA8513
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: RIGHT ANGLE ELECTRODE WITH SUCTION
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg,
• MDR Report Key: 10440224
• Report Number: 1421101-2020-00003
• Device Sequence Number: 2171468
• Product Code: GEI
• UDI-Device Identifier: 10885403054051
• UDI-Public: 10885403054051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other