MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW HANDPIECE, 34CM, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3904
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to microline surgical, inc.An investigation cannot be performed at this time.
Event or Problem Description
Male patient in the or for a laparoscopic right inguinal hernia repair.During the procedure, the surgeon fired the handpiece of the laparoscopic scissors prior to using them on the patient.When he did that, the handpiece arced and caused a spark and smoke to come from the tip of the handpiece, which burned through the rubber insulation on the side.The instrument was immediately removed and a new scissor tips and handle were obtained.The procedure continued as planned.

• Brand Name: RENEW HANDPIECE, 34CM, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8741260
• Report Number: 1223422-2019-00015
• Device Sequence Number: 2534817
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 3904
• Device Catalogue Number: 3904
• Device Lot Number: 00116779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR