Proximate PRW35Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705036013020), received between Jan 14, 2019 and Mar 2, 2026 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Mechanics Altered

  PER USER FACILITY MEDWATCH FORM, MW5181860, THAT DURING AN UNKNOWN PROCEDURE, ETHICON PROXIMATE ROTATING HEAD STAPLER WAS USED ON PATIENT WHEN THEY WERE FINISHED WITH PT'S SECTION. BEFORE PUTTING THE DRESSING ON THEY NOTICED 2 STAPLES COMING OUT AND HAD TO REPLACE THEM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489576 ↗
• MalfunctionDec 17, 2025Misfire

  SKIN STAPLER MISFIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827552 ↗
• InjuryDec 10, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, A FEW DAYS AFTER A RIGHT CRANIOTOMY PROCEDURE FOR SUBDURAL HEMATOMA, THE SURGEON STATED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE SURGEON ALSO NOTED THAT THE SKIN STAPLER DID NOT FUNCTION PROPERLY IN CLOSING THE WOUND.

  Patient problems: Wound Dehiscence

  MAUDE report 23767323 ↗
• MalfunctionOct 27, 2025Misfire

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390244 ↗
• MalfunctionJul 1, 2025Mechanics Altered; Firing Problem; Mechanics Altered; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER PRESENTED FAILURE IN THE SKIN CLOSURE AND BREAKAGE OF THE STAPLES. IT IS NECESSARY TO OPEN ANOTHER MATERIAL FOR CLOSING THE SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372024 ↗
• MalfunctionMar 31, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER FAILED DURING USE, FIRING BENT STAPLES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731095 ↗
• InjuryFeb 6, 2025Mechanics Altered; Firing Problem; Mechanics Altered; Firing Problem

  PER USER FACILITY MEDWATCH FORM, #(B)(4), DURING AN UNKNOWN SURGERY; STAPLER WAS NOT DISPENDING STAPLES PROPERLY AND DESTROYED UNLAYING TISSUE, PER SURGEON, AND INCISION HAD TO BE REOPENED AND REPOSITIONED TO CLOSE WOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21324923 ↗
• MalfunctionJan 28, 2025

  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.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21252099 ↗
• MalfunctionNov 12, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE STAPLES DID NOT CLOSE PROPERLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662658 ↗
• MalfunctionNov 12, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE STAPLES DID NOT CLOSE PROPERLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662317 ↗
• InjuryJun 20, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT AFTER AN OPEN UNKNOWN PROCEDURE, PATIENT HAD SURGERY IN THE MIDDLE OF THE NIGHT, THE STAPLES FELL OUT POST SURGERY. PATIENT WILL BE GOING BACK TODAY TO BE SUTURED SHUT FROM ALL THREE LAYERS.

  Patient problems: Wound Dehiscence

  MAUDE report 19576715 ↗
• MalfunctionMar 6, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT THE STAPLER DID NOT WORK DURING THE SHOT. PROCEDURE: UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491136 ↗
• MalfunctionJan 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THEY OPENED UP NEW PRODUCT, THE OUTSIDE BOX VSTL35 BUT THE INTERIOR HAD PRW35. PRW35 WILL BE AVAILABLE FOR RETURN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246337 ↗
• InjuryDec 16, 2022Patient Device Interaction Problem; Firing Problem; Patient Device Interaction Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, "TODAY IN OUR OR, ONE OF THE SKIN STAPLERS GUNS THE SURGEON WAS USING DID NOT WORK. IT WOULD NOT STAPLE AND INSTEAD REMAINED JAMMED." (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15999752 ↗
• InjuryJun 29, 2021Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY HAD TO BRING A PATIENT BACK IN TO THE OPERATING ROOM ON SATURDAY AFTER A FRIDAY CASE DUE TO SKIN STAPLES NOT HOLDING THE INCISION CLOSED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12084214 ↗
• MalfunctionJan 4, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DEVICE FIRED THE FIRST FEW STAPLES CORRECTLY THEN JAMMED. SURGERY WAS DELAYED BY 4-MINUTES WITH NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108788 ↗
• MalfunctionAug 7, 2020Failure to Discharge; Defective Component

  THE ETHICON ENDO-SURGERY PROXIMATE ROTATING HEAD SKIN STAPLERS DEVICE (MODEL PRW35) WAS USED ON A PATIENT DURING A SURGICAL CASE. THE DEVICE WORKED AS EXPECTED WITH THE FIRST THREE STAPLES. THEN, THE DEVICE MALFUNCTIONED AND WOULD NOT LOAD OR DISCHARGE ANY MORE STAPLES. THE DEFECTIVE DEVICE WAS REMOVED FROM THE SURGICAL FIELD AND PLACED IN A BAG WHILE A NEW PROXIMATE DEVICE WAS OPENED TO CONTINUE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10380413 ↗
• MalfunctionMar 26, 2020Defective Device

  OPERATING ROOM STAFF REPORTED THAT A STAPLER WAS NOT WORKING DURING A PROCEDURE. A NEW STAPLER WAS OPENED AND USED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO HARM TO THE PATIENT, AND THE STAPLER WILL BE RETURNED TO THE MANUFACTURER BY OR MATERIAL'S MANAGEMENT STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9882561 ↗
• MalfunctionMar 6, 2019Defective Component

  ROTATING HEAD SKIN STAPLER WOULD NOT WORK - WOULD NOT STAPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8394189 ↗
• MalfunctionJan 14, 2019Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "HOLE NOTED IN PACKAGING BEFORE OPENING PRODUCT." THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245099 ↗