MAUDE Adverse Event Report: MICROLINE SURGICAL INC RENEW HANDPIECE, 34CM, REUSABLE; ELECTROSURGICAL HANDPIECE, ELECTRODE/MONOPOLAR, REUSABLE

Model Number	3904
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, msi is awaiting the device back from the hospital so a full investigation can be conducted.Once the investigation is complete and more information is available, a final adverse event report will be submitted.
Event or Problem Description
Patient underwent a laparoscopic ovarian cystectomy.Intraoperatively, monopolar scissor cauterized at the junction between the scissor tip and handpiece handle causing left iliac artery bleed with 1000cc blood loss.Patient required one unit of prbcs transfusion.Vascular surgery and general surgery consulted, and patient underwent emergency laparotomy with left external iliac artery repair.Unknown extended anesthesia time.Laparoscopic ovarian cystectomy procedure started at 09:52.Incident occurred around 11:00 and patient underwent emergent laparotomy with left external ilian artery repair.Procedure ended at 13:22.
Additional Manufacturer Narrative
Despite requests from the manufacturer, the device was not returned to msi.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 underwent a laparoscopic ovarian cystectomy.Intraoperatively, monopolar scissor cauterized at the junction between the scissor tip and handpiece handle causing left iliac artery bleed with 1000 cc blood loss.Patient required one unit of prbcs transfusion.Vascular surgery and general surgery consulted, and patient underwent emergency laparotomy with left external iliac artery repair.Unknown extended anesthesia time.Laparoscopic ovarian cystectomy procedure started at 09:52.Incident occurred around 11:00 and patient underwent emergent laparotomy with left external ilian artery repair.Procedure ended at 13:22.

• Brand Name: RENEW HANDPIECE, 34CM, REUSABLE
• Common Device Name: ELECTROSURGICAL HANDPIECE, ELECTRODE/MONOPOLAR, 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: 21945330
• Report Number: 1223422-2025-00012
• Device Sequence Number: 8720339
• Product Code: GEI
• UDI-Device Identifier: 00811099010548
• UDI-Public: 00811099010548
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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
• Device Lot Number: 53846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/14/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown