MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC PROXIMATE; STAPLE, REMOVABLE (SKIN)

Model Number	PRW35
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per staff report: stapler was not dispending staples properly and destroyed unlaying tissue, per surgeon, and incision had to be reopened and repositioned to close wound.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 21252099
• Report Number: 21252099
• Device Sequence Number: 15743451
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: (01)10705036013020(17)290930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/16/2025
• Report Date (Section F): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PRW35
• Device Catalogue Number: PRW35
• Device Lot Number: 307D57
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/16/2025