PROXIMATE TLH60Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705036013235), received between Dec 20, 2017 and Jan 9, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A THORACOTOMY, THE DEVICE DIDN¿T MAKE THE STAPLE LINE AT ALL. THE HEART AND THORACIC SURGEON HAS USED THIS DEVICE MORE THAN 15 YEARS. THIS WAS A FIRST TIME, WHEN IT MADE THE "TRICK"! THE SURGERY WAS DELAYED BY 15-MINUTES. THEY USED AN ENDOCUTTER WHEN THIS EVENT OCCURRED. FRAGMENTS WERE GENERATED BUT REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121299 ↗
• InjuryMay 19, 2022Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LOW ANTERIOR RESECTION. THE PATIENT HAD A HISTORY OF CONSTIPATION AND COMPLEX PELVIC CYSTIC MASS (> 15 CM) UNDERWENT MASS RESECTION WAS DEEMED NECESSARY. MEDICAL RECORDS PROVIDED STATE THAT PREOPERATIVELY, THE MASS APPEARED TO BE SEPARATE FROM THE LUMEN OF THE RECTUM; HOWEVER, INTRAOPERATIVELY THE SURGEON FELT THEY COULD NOT RESECT THIS MASS WITHOUT A LOW ANTERIOR RESECTION OF THE RECTUM. OPERATIVE NOTE FURTHER STATES A ¿TA STAPLER¿ WAS FIRED ACROSS THE DISTAL RECTUM, WHICH APPEARED TO FIRE WITHOUT DIFFICULTY. DISSECTION WAS CONTINUED ALONG THE CAUDAL ASPECT OF THE MASS WITH LIGASURE AND THE MASS AND RECTAL TISSUE WERE EXCISED. UPON DIGITAL EXAMINATION OF THE STUMP, IT WAS DETERMINED THAT THE ENTIRE TA STAPLE LINE FAILED ¿APPEARED AS IF NO STAPLES HAD FIRED ACROSS THE SMALL BOWEL.¿ SURGEON PERFORMED AN INTERRUPTED HANDSEWN CLOSURE OF THE RECTAL STUMP AND ¿REPEAT DIGITAL RECTAL EXAMINATION DEMONSTRATED AN INTACT RECTAL POUCH.¿ AN END-TO-END ANASTOMOSIS WAS PERFORMED BETWEEN THE RECTAL STUMP AND THE DISTAL SIGMOID COLON ¿DESPITE THE FACT THAT WE KNEW THERE WOULD BE HIGH RISK OF LEAK, WE FELT THIS WAS OUR BEST OPPORTUNITY FOR LONG TERM CONT

  Patient problems: Abscess; Failure to Anastomose; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 14436601 ↗
• MalfunctionNov 11, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE NURSE JUST ROUGHLY INDICATED THAT THE STAPLER DID NOT FORM WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798480 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: SIDE-TO-END VS. STRAIGHT STAPLED COLORECTAL ANASTOMOSIS AFTER LOW ANTERIOR RESECTION: RESULTS OF RANDOMIZED CLINICAL TRIAL AUTHOR: E.G. RYBAKOV, D. YU PIKUNOV, O. YU FOMENKO, S. V. CHERNYSHOV, YU A. SHELYGIN CITATION: INT J COLORECTAL DIS (2016) 31:1419¿1426; DOI 10.1007/S00384-016-2608-4, PUBLISHED ONLINE: 30 MAY 2016. THE AIM OF THIS STUDY IS TO COMPARE SURGICAL, FUNCTIONAL, PHYSIOLOGIC OUTCOMES AND QOL AFTER LOW ANTERIOR RESECTION (LAR) WITH AND SIDE-TO-END OR STRAIGHT COLORECTAL ANASTOMOSIS. BETWEEN 2012 AND 2015, THERE WERE 81 PATIENTS INCLUDED AND WERE RANDOMIZED INTO TWO GROUPS: SIDE-TO-END, 13 MALES, 28 FEMALES, AGE RANGE: 51 TO 65 YEARS, BMI= 25-29 AND STRAIGHT, 20 MALES, 20 FEMALES, AGE RANGE: 58 TO 69 YEARS, BMI= 2 7-30. DURING THE PROCEDURE, RECTAL DISSECTION WAS PERFORMED IN MESORECTAL PLANE WITH TOTAL MESORECTAL EXCISION (TME). DURING THE PROCEDURE, THE CONTOUR® CURVED CUTTER STAPLER (ETHICON ENDO-SURGERY, INC.) WAS APPLIED AT THE SITE OF THE ANORECTAL JUNCTION TO CLOSE THE RECTAL STUMP. A DOUBLE-STAPLING TECHNIQUE WAS USED BOTH FOR STRAIGHT OR SIDE-TO-END COLORECTAL ANASTOMOSIS. A PREMIUM PLUS CEEA¿ 31 STAPLER (COVIDIEN, USA)

  Patient problems: Blood Loss; Fistula; No Code Available; Urinary Retention

  MAUDE report 7742246 ↗
• MalfunctionMay 30, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING THE COLECTOMY, AFTER FIRED, FOUND THE STAPLES MALFORMED WHEN SEVERING THE COLON. SUTURE WAS USED TO SEW THE WOUND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552281 ↗
• MalfunctionMar 14, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DIDN'T APPLY THE CLIPS. THE RELOAD WAS REPLACED THE ISSUE WAS SOLVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7337500 ↗
• MalfunctionDec 20, 2017Material Deformation

  IT WAS REPORTED THAT DURING THE RADICAL RECECTION OF LEFT COLON, AFTER FIRED, FOUND HALF OF STAPLE LINE MALFORMED WITH STRAIGHT LEG. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7134001 ↗