MAUDE Adverse Event Report: EXSURCO MEDICAL MESHEX; EXPANDER, SURGICAL, SKIN GRAFT

Model Number	X101866
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Cut (2587); Mechanics Altered (2984)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received by the manufacturer for review.No anomalies were identified as a part of a review of production records.
Event or Problem Description
During a procedure on (b)(6) 2026, it was reported that during the skin graft meshing utilizing a 3:1 cutting roller there were many missed cuts along the grafts.Due to the amount of missed cuts, another piece of skin had to be taken from the patient.A procedure delay of unknown length occurred due to re-cutting holes manually and retrieving more skin.Reported roller: x101866 meshex msh cutting roller c sn: (b)(6).

• Brand Name: MESHEX
• Common Device Name: EXPANDER, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): EXSURCO MEDICAL; 10804 green rd; wakeman OH 44889
• Manufacturer (Section G): EXSURCO MEDICAL; 10804 green rd; wakeman OH 44889
• Manufacturer Contact: jessica zurcher ; 10804 green rd; wakeman, OH 44889 ; 4403704747
• MDR Report Key: 24523699
• Report Number: 3011981870-2026-00001
• Device Sequence Number: 12890354
• Product Code: FZW
• UDI-Device Identifier: 00810006780192
• UDI-Public: 00810006780192
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: X101866
• Device Catalogue Number: X101866
• Device Lot Number: X-0000000000003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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: Required Intervention
• Patient Sex: Unknown