MAUDE Adverse Event Report: Zhejiang Shuyou Surgical PMI; PMI PTFE Coated Modified Blade 2.5in

Model Number	P0012M
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial reporter stated a patient experienced burns from an electrosurgical electrode during a breast augmentation on (b)(6) 2026 and the experience outcome was extended patient hospitalization.No further clinical details, patient demographics, or identifiers were provided in the initial report.Documented follow-up attempts for additional information were made on or around 06/26/2026, 07/03/2026, and 07/09/2026.The distributor that received the report also made several follow-up attempts between 06/04/2026 and 06/26/2026.No additional patient or event information could be obtained.

• Brand Name: PMI
• Common Device Name: PMI PTFE Coated Modified Blade 2.5in
• Manufacturer (Section D): Zhejiang Shuyou Surgical; no. 3689 yangguang av, dipu st; anji county; huzahou city, zhejiang 31330 0; CH 313300
• MDR Report Key: 50016207
• Report Number: 3009495876-2026-00001
• Device Sequence Number: 9517040
• Product Code: GEI
• UDI-Device Identifier: 00812608020348
• UDI-Public: 00812608020348
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/24/2026
• Report Date (Section F): 07/24/2026

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: P0012M
• Device Catalogue Number: P0012M
• Device Lot Number: 2509110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2026
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown