PROXIMATE TL60Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705036013181), received between Feb 22, 2018 and Dec 31, 2019 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES DEPLOYED BUT DID NOT FORM CORRECTLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535469 ↗
• MalfunctionMay 15, 2019Failure to Form Staple

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613628 ↗
• MalfunctionMar 15, 2019Break

  IT WAS REPORTED: DAMAGED DEVICE. DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, ROTATING THE KNOB, NOTED THE PLASTIC SHELL OF HANDLE 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 Consequences Or Impact To Patient

  MAUDE report 8426292 ↗
• MalfunctionJan 4, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE STAPLER IS VERY HARD AND AT THE TIME OF SHOOTING THE DEVICE WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217162 ↗
• MalfunctionDec 3, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN WHIPPLE PROCEDURE, THE DEVICE DID NOT STAPLE. THERE IS NO FURTHER INFORMATION AVAILABLE ABOUT THE EVENT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124799 ↗
• MalfunctionNov 5, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SOME STAPLES DID NOT FORM B-SHAPE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037102 ↗
• InjuryJul 30, 2018Output below Specifications; Firing Problem

  IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: THREE YEAR RESULT OF LAPAROSCOPIC VERTICAL BANDED GASTROPLASTY AUTHOR : ERIK NASLUND, JACOB FREEDMAN, JESPER LAGERGREN, DAG STOCKELD, LARS GRANSTROM CITATION: OBESITY SURGERY, 9, 369-373, 1999. THE STUDY AIMED TO EVALUATE THE RESULTS OF THE LAPAROSCOPIC VERTICAL BANDED GASTROPLASTY (VBG) IN 60 PATIENTS WITH A FOLLOW-UP OF 6-36 MONTHS. BETWEEN JAN1995 AND FEB1998, 60 MASSIVE OBESITY PATIENTS (N=10 MALE AND N=50 FEMALE; AGE OF 41.9±1.4 YEARS) LAP VBG WHERE 15 CASES WERE CONVERTED TO OPEN VBG DUE TO LARGE LEFT LOBE OF THE LIVE (N=13), GASTRIC PERFORATION (N=1) AND SPLENIC INJURY (N=1). IN THE LAP VBG, THE UPPER MIDLINE PORT WAS CHANGED TO A 33-MM PORT (LKT 33 ¿ ETHICON) AND THE ECS 25 CIRCULAR STAPLER WAS INTRODUCED AND FIRED WITH A 32F NASOGASTRIC CATHETER PLACED IN THE STOMACH ALONG THE LESSER CURVATURE TO GUIDE THE POSITIONING OF THE STAPLER. THE LEFT WORKING PORT WAS CHANGED TO AN 18-MM PORT (TEC 18 ¿ ETHICON) AND THE 60-MM ETC 460 LINEAR STAPLER WAS INTRODUCED AND PLACED ALONGSIDE THE 32F CATHETER THROUGH THE CIRCULAR HOLE UP TO THE ANGLE OF HIS. TWO PATIENTS IN THE LAP VBG GROUP WERE FOUND TO HAVE STAPLE-LINE DISRUPTION. THE STAPL

  Patient problems: No Code Available

  MAUDE report 7733172 ↗
• MalfunctionJun 28, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RESECTION OF GASTRIC CANCER, AFTER FIRED, FOUND SOME OF STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 7647059 ↗
• MalfunctionJun 4, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A RIGHT COLECTOMY PROCEDURE UPON CLOSING THE DEVICE ONLY PART OF THE STAPLE LINE FORMED. SOME WERE GOAL POSTS. THE LAST QUARTER OF THE LINE WERE NOT FORMED PROPERLY. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7565114 ↗
• MalfunctionFeb 22, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, IN THE MIDDLE OF THE CASE, THE SURGEON FIRED THE DEVICE BUT NO STAPLES WERE DEPLOYED. UPON EXAMINATION, NO STAPLES WERE SEEN ON THE SPECIMEN EITHER, CLOSER VIEW INDICATED THAT THE STAPLING DEVICE DIDN'T HAVE ANY STAPLES. THE SURGEON WANTED TO SEND THE SPECIMEN TO THE LAB FOR EXAMINATION UNDER THE MICROSCOPE. NO DELAY IN SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7288937 ↗