Proximate PPH03Recalls & reported problems

Summary

The FDA's MAUDE database contains 389 adverse event reports that list this exact device (DI 10705036013006), received between Jul 20, 2015 and Aug 12, 2026 — classified as 129 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (122 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 389 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Form Staple; No Apparent Adverse Event

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222145 ↗
• MalfunctionMar 3, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Firing Problem

  IT WAS REPORTED THAT DURING A PROLAPSE, STAPLER BLOCKED DURING INSERTION. IN A LONGO SURGERY. IT WAS NEEDED TO RESECT THE TISSUE IN A VERY LOW POSITION TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 24498025 ↗
• MalfunctionFeb 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE DIDN'T FIRE DURING HEMORRHOID SURGERY IT WAS GRADE 3. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239202 ↗
• MalfunctionDec 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CANNOT FIRE, UNABLE TO PUSH THE TRIGGER. NO OTHER DETAILS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773261 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THEY WERE ABLE TO FIRE THE DEVICE BUT WITH INCOMPLETE DONUT MUCOSA IS NOT CONNECTING AFTER THE FIRING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543479 ↗
• MalfunctionNov 12, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A COLON ANASTOMOSIS SURGERY IN A PATIENT TREATED BY DR., THE STAPLER WAS USED. WHEN SHOOTING, THE STAPLER DID NOT PERFORM STAPLING AND STOPPED WORKING. THIS CAUSED EXCESSIVE BLEEDING AND THE SURGERY WAS PROLONGED, AS MANUAL STAPLING WAS NECESSARY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533194 ↗
• MalfunctionNov 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN PERFORMING THE SECTION WITH THE PPH STAPLER, THE SURGEON FOUND PARTIAL FORMATION OF THE STAPLING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510852 ↗
• MalfunctionAug 8, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE STAPLER FAILURE AFTER ACTIVATION; RESECTION WAS NOT PERFORMED, AND MUCOSAL LACERATION OCCURRED WITHOUT STAPLING OR RESECTION ACTIVATION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 22748245 ↗
• MalfunctionJul 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON THE END OF THE SCOPE THE WAS A MARKING ON IT AND THEY ARE WORRIED THAT IT WASN'T STERILE. THEY ENDED UP OPEN NEW ONE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519581 ↗
• MalfunctionJul 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN TRIGGERED THE STAPLER, HE CUT THE SKIN, BUT DID NOT STAPLE IT, AND IT WAS NOT POSSIBLE TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506264 ↗
• InjuryJul 11, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE CIRCULAR STAPLER AND THE STAPLES DID NOT HOLD WITH MASSIVE BLEEDING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478546 ↗
• MalfunctionJun 20, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE SURGEON FIRED THE STAPLER , BUT IT DEPLOYED PARTIALLY, RESULTING IN INCOMPLETE STAPLING AND CUTTING OF SPECIMEN, WHICH LED TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296642 ↗
• MalfunctionMay 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GUN GOT STUCK AND DURING FIRING SEQUENCE. SHOOTING IS INCOMPLETE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044372 ↗
• MalfunctionApr 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE SURGEON COULDN'T DRAW THE RED SAFETY BACK TOWARD THE ADJUSTING KNOB. WHEN THEY TRIED TO DRAW THE RED SAFETY BACK TOWARD THE ADJUSTING KNOB, THERE WERE A LOT OF STAPLES FALLING OUT OF THE INSTRUMENT ALTHOUGH HE DIDN'T SQUEEZE THE FIRING HANDLE. THE SURGERY WAS DELAYED 30 MINUTES. REMOVE THE PURSE-STRING SUTURE TO THE ANVIL SHAFT OF THIS INSTRUMENT AND REPLACE ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892035 ↗
• MalfunctionApr 22, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE STAPLER WAS LOCKED, IT WAS NOT POSSIBLE TO USE IN SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881434 ↗
• MalfunctionApr 22, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY, USING STAPLER. PROFESSIONAL REPORTED THAT WHEN HE TRIGGERED THE STAPLER, HE CUT THE SKIN, BUT DID NOT STAPLE IT, AND IT WAS NOT POSSIBLE TO USE IT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881270 ↗
• MalfunctionApr 21, 2025Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE PURSE-STRING SUTURE WAS TIED, THE STAPLER WAS INSERTED AND CLOSED UNDER VISUAL CONTROL, THE SAFETY DEVICE WAS RELEASED, AND AT THIS MOMENT THE LONGITUDINAL SEAM OF THE PLASTIC TRAY SPLIT LENGTHWISE (STILL VISIBLE). THE STAPLER COULD NOT BE RELEASED. PRESSURE MARKS WERE VISIBLE ON THE MUCOUS MEMBRANE. THE STAPLER DID NOT STAPLE, AND EVERYTHING COULD BE REMOVED SAFELY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873346 ↗
• InjuryMar 19, 2025Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Ejection Problem; Failure to Eject; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Ejection Problem; Failure to Eject

  IT WAS REPORTED THAT DURING A HEMORRHOID SURGERY, THERE WAS RESISTANCE DURING REMOVAL. THERE WAS A LOT OF BLEEDING AFTER REMOVAL, AND THE ARTERIAL BLEEDING WAS STOPPED BY SUTURING. FOR VENOUS HEMOSTASIS, A BALLOON USED FOR ESOPHAGEAL VARICES WAS PLACED AND THE OPERATION WAS COMPLETED (TSB TUBE 5.3 MM 16 FR). THE ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE NEXT DAY BLEEDING WAS FOUND AND STOPPED BY ENDOSCOPY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ulcer

  MAUDE report 21645058 ↗
• MalfunctionMar 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE DEVICE DID NOT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632600 ↗
• InjuryMar 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A PROSPECTIVE AND COMPARATIVE STUDY OF SHORT TERM RESULTS OF OPEN HEMORRHOIDECTOMY VERSUS STAPLED HEMORRHOIDOPEXY AUTHORS: DR. REEGAN JOSE.M1, DR. NIVEDHA.R2, DR. SRINIDHI.K3 CITATION:JOURNAL OF PHARMACEUTICAL NEGATIVE RESULTS/ DOI: 10.47750/PNR.2022.13.S09.825. THE AIM OF PROSPECTIVE AND COMPARATIVE STUDY WAS TO COMPARE THE SHORT TERM RESULTS OF STAPLED HEMORRHOIDOPEXY(SH) WITH OPEN HEMORRHOIDECTOMY(OH) WITH RESPECT TO OPERATING TIME, POST-OPERATIVE PAIN AND IMMEDIATE POST-OPERATIVE COMPLICATIONS. BETWEEN JUNE 2014 TO AUGUST 2015, A TOTAL OF NINETY PATIENTS (57 MALE AND 33 FEMALE WITH MEAN AGE OF 21->60 YEARS OLD) UNDERGOING SURGERY FOR HEMORRHOIDS AT SRM MEDICAL COLLEGE, KATTANKULATHUR ,WHO FULFILLED THE CRITERIA WERE INCLUDED IN THE STUDY. FORTY FIVE PATIENTS UNDERWENT MILLIGAN MORGAN TECHNIQUE OF OPEN HEMORRHOIDECTOMY AND FORTY FIVE PATIENTS UNDERWENT LONGO TECHNIQUE OF STAPLED HEMORRHOIDOPEXY. THE STAPLED PROCEDURE WAS PERFORMED ACCORDING TO THE TECHNIQUE DESCRIBED BY LONGO. A 33-MM CIRCULAR STAPLING DEVICE PART OF PPH03 KIT (PROXIMATE; ETHICON ENDOSURGERY, CINCINNATTI, OHIO, USA) WAS USED .THE PPH03 KIT INCLUDES ALL OF THE REQUIRED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21576954 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: THEN LEAVE ED AS IS. TITLE: RANDOMIZED CONTROLLED TRIAL TO COMPARE STAPLED HEMORRHOIDOPEXY PLUS LIGATION ANOPEXY WITH STAPLED HEMORRHOIDOPEXY FOR MANAGING GRADE III AND IV HEMORRHOIDAL DISEASE AUTHORS: WALID GALAL ELSHAZLY, M.D. ¿ MOHMED ABDELHALIM ABO ELROS, F.R.C.S. AMR SAMIR ALI, F.R.C.S. ¿ AHMED MOHAMED RADWAN, F.R.C.S. CITATION: DIS COLON RECTUM 2024; 67: 812¿819 DOI: 10.1097/DCR.0000000000003273. . THE PURPOSE OF THIS RANDOMIZED CONTROLLED STUDY WAS TO COMPARE THE SHORT-TERM AND LONG-TERM OUTCOMES OF STAPLED HEMORRHOIDOPEXY (SH) ALONE VERSUS STAPLED HEMORRHOIDOPEXY PLUS LIGATION ANOPEXY (SH + LA), FOCUSING ON RECURRENCE, PATIENT SATISFACTION, PAIN, COMPLICATIONS, AND QUALITY OF LIFE AFTER SURGERY. BETWEEN JANUARY 2018 AND (B)(6) 2020, A TOTAL OF 124 PATIENTS WITH GRADE III AND IV HEMORRHOIDS. THE MEAN AGE WAS 43.1± 11.6 IN GROUP I, AND 43.7± 10.8 IN GROUP II. MOST PATIENTS WERE WOMEN 33 IN GROUP I AND 32 IN GROUP II. MOST PATIENTS HAD GRADE III HEMORRHOIDAL DISEASE 39 IN GROUP I AND 40 IN GROUP II. THE SURGERY PERFORMED WAS STAPLED HEMORRHOIDOPEXY (SH) IN GROUP I AND STAPLED HEMORRHOIDOPEXY PLUS LIGATION ANOPEXY (SH + LA) IN GROUP II. BOTH

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21525006 ↗
• MalfunctionFeb 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY AFTER FIRING THE GUN AND REMOVING IT, IT BECAME APPARENT THAT THE GUN DID NOT CONTAIN STAPLES, AND THE OPERATION FAILED. THE OPERATION HAD TO BE REPEATED AGAIN USING A NEW STAPLE GUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457704 ↗
• MalfunctionFeb 24, 2025Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event; Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PROCEDURE FOR PROLAPSE AND HEMORRHOIDS, WHEN THE TIP WAS TRIED TO CLOSE IT WAS VERY TIGHT AND THE TIP COULDN'T TURN ALL THE WAY. IT WAS USED ON ANUS. IT WAS FORCED TO BE CLOSED AND COULD BE FIRED. BUT SUTURE FAILURE OCCURRED AND THERE WAS BLEEDING. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447904 ↗
• MalfunctionFeb 21, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY THE STAPLE DID NOT FORM. CAN'T FIRE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432113 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER USER FACILITY MEDWATCH FORM, #MW5164942, THE SURGEON STAPLED HEMORROIDOPEXY WITH ETHICON HEMORRHOID PPH STAPLER CPT 46947 AND RETURNED TO THE ED THE FOLLOWING DAY WITH RECTAL BLEEDING. THIS WAS REPORTED FROM HOME AND OBSERVED IN THE ED. PATIENT TO THE OR FOR ANORECTAL EXAM AND, ALTHOUGH NO ACTIVE BLEEDING WAS NOTED AT THAT TIME, THE STAPLE LINE WAS REINFORCED WITH SUTURES AND SHE WAS DISCHARGED. PATIENT PRE-OP HEMOGLOBIN WAS 16, ON ARRIVAL TO EMERGENCY ROOM ON 1-7 WAS 14 AND THEN TO 12.4. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21374845 ↗