MAUDE Adverse Event Report: Microline Surgical, Inc. REVEEL Endoscopic Retractor - Percutaneous

Model Number	RV093001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the laparoscopic procedure, while performing liver retraction, a scratch-related lesion was created.
Additional Manufacturer Narrative
Microline surgical is awaiting return of the device in order to perform an investigation.

• Brand Name: REVEEL Endoscopic Retractor - Percutaneous
• Common Device Name: Endoscopic Retractor
• 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
• MDR Report Key: 50194240
• Report Number: 1223422-2026-00009
• Device Sequence Number: 10009581
• Product Code: GCJ
• UDI-Device Identifier: 00811099014386
• UDI-Public: 00811099014386
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: RV093001
• Device Catalogue Number: RV093001
• Device Lot Number: 2505292
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male