MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW HANDPIECE, 34CM, REUSABLE; LAPAROSCOPIC HANDPIECE, REUSABLE

Model Number	3904
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing (2583)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was taken back for a diagnostic laparoscopic procedure for endometriosis lesions.Two lesions were removed with the monopolar scissors and laparoscopic grasper.The lesion was removed and upon moving further away from the site with the camera, it was identified that the monopolar scissor had burned the fundal serosa of the uterus in 2 locations as well as the left fallopian tube superficially.This was done at the connection of the monopolar scissors to the laparoscopic instrument and a fault in the insulation of this connection.The scissor tips and the laparoscopic instrument were immediately switched out for a new set and were working appropriately.
Additional Manufacturer Narrative
At this time, microline surgical is awaiting information from the hospital to see if the affected device can be returned so an investigation can be completed.Once the results of the investigation are available, a final adverse event report will be submitted.
Additional Manufacturer Narrative
Despite requests from microline surgical, the affected item was never returned, so an investigation could not be conducted.Since the associated product was not returned to msi for investigation within 30+ days, the complaint was closed per pmf-q2-001.
Event or Problem Description
Patient was taken back for a diagnostic laparoscopic procedure for endometriosis lesions.Two lesions were removed with the monopolar scissors and laparoscopic grasper.The lesion was removed and upon moving further away from the site with the camera, it was identified that the monopolar scissor had burned the fundal serosa of the uterus in 2 locations as well as the left fallopian tube superficially.This was done at the connection of the monopolar scissors to the laparoscopic instrument and a fault in the insulation of this connection.The scissor tips and the laparoscopic instrument were immediately switched out for a new set and were working appropriately.

• Brand Name: RENEW HANDPIECE, 34CM, REUSABLE
• Common Device Name: LAPAROSCOPIC HANDPIECE, REUSABLE
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 20907263
• Report Number: 1223422-2024-00048
• Device Sequence Number: 4008556
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3904
• Device Catalogue Number: 3904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female