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

Model Number	PRW35
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of the craniotomy procedure, second assist pa-c (provider) was closing the skin with a skin stapler.The stapler misfired.Provider attempted to fire again to release the staple and multiple staples deployed.Tried cleaning the stapler and testing on a towel.Stapler continued to misfire.Staples needed to be removed from patient.Misfired staples were removed from patient.New stapler was used to close skin.Surgeon was notified who assessed patient's skin and nothing further needed, no apparent harm.

• 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: 23390244
• Report Number: 23390244
• Device Sequence Number: 18686805
• Product Code: GDT
• UDI-Device Identifier: 10705036013020
• UDI-Public: (01)10705036013020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2025
• Report Date (Section F): 10/02/2025

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
• Operator of Device: Other
• Device Model Number: PRW35
• Device Catalogue Number: PRW35
• Device Lot Number: 654D66
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Date Report Sent to FDA: 10/02/2025