MAUDE Adverse Event Report: Microline Surgical, Inc. ReNew Ratcheted Handpiece, 34cm; Manual Detachable Surgical Instruments

Model Number	3914
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
While treating / ablating tissue (endometrial ablation) unintended tissue was burned.A minor burn occured in the pelvic cavity.
Additional Manufacturer Narrative
Microline surgical is awaiting return of the device so an investigation can be performed.

• Brand Name: ReNew Ratcheted Handpiece, 34cm
• Common Device Name: Manual Detachable Surgical Instruments
• Manufacturer (Section D): Microline Surgical, Inc.; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer (Section G): Microline Surgical; 50 dunham rd; suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand-davis ; 50 dunham rd; suite 1500; beverly, MA 01915
• MDR Report Key: 50345531
• Report Number: 1223422-2026-00011
• Device Sequence Number: 10256053
• Product Code: GEI
• UDI-Device Identifier: 00811099010579
• UDI-Public: 00811099010579
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/02/2026

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: Health Professional
• Device Model Number: 3914
• Device Catalogue Number: 3914
• Device Lot Number: 39472
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 140 LB