Proximate PMW35Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 10705036002642), received between Apr 1, 2013 and Mar 13, 2026 — classified as 40 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (107 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590895 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582898 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582730 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582167 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582149 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582126 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582098 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581973 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581874 ↗
• MalfunctionMar 12, 2026Mechanics Altered; Firing Problem

  THE CUSTOMER REPORTED THAT THE STAPLES ON THE STAPLER WERE NOT CLOSING, WERE BENDING, OR WERE SIMPLY FALLING OUT OF THE DEVICE. THE PROBLEM WAS INITIALLY MONITORED TO RULE OUT USER ERROR, BUT THE ISSUE OCCURRED WITH DIFFERENT USERS. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581787 ↗
• MalfunctionMar 2, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, USING A SKIN STAPLER RESULTED IN POOR STAPLE FORMATION. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490337 ↗
• MalfunctionMar 2, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, USING A SKIN STAPLER RESULTED IN POOR STAPLE FORMATION. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490301 ↗
• MalfunctionFeb 27, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474827 ↗
• MalfunctionFeb 27, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474265 ↗
• MalfunctionFeb 24, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431400 ↗
• MalfunctionJan 14, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE HEART SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066601 ↗
• MalfunctionJan 14, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066485 ↗
• MalfunctionJan 14, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066475 ↗
• MalfunctionJan 12, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037441 ↗
• MalfunctionJan 12, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037116 ↗
• MalfunctionJan 8, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010773 ↗
• MalfunctionJan 8, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010730 ↗
• MalfunctionJan 5, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956085 ↗
• MalfunctionJan 5, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER CANNOT HOLD THE STAPLES. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955959 ↗
• MalfunctionDec 31, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING THE NEPHRECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY, THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934386 ↗