PROXIMATE TL90Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705036013198), received between Dec 12, 2017 and Apr 20, 2021 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "RECEIVED NOTICE OF CLAIM WHICH STATES CLAIMANT UNDERWENT A HEMICOLECTOMY FOR DISTAL TRANSVERSE COLON CANCER (ADENOCARCINOMA) DURING WHICH A SIDE TO SIDE, FUNCTIONAL END TO END ANASTOMOSIS WAS CREATED USING A GIA STAPLER AND A TA STAPLER WAS USED TO CLOSE THE ENTEROTOMY. ON THE FIFTH POSTOPERATIVE DAY, PATIENT UNDERWENT REPAIR OF PINHOLE ANASTOMOTIC LEAK. SURGEON NOTED NO GROSS CONTAMINATION OR SIGNIFICANT FREE AIR UPON OPENING. AN INTERNAL HERNIA WAS ALSO REPAIRED: HOWEVER VERY LIMITED INFORMATION WAS PROVIDED. CLAIM FORM STATES PATIENT RECEIVED AN ILEOSTOMY ON (B)(6) 2019; HOWEVER, NO RECORDS ARE PROVIDED WITH ANY DETAILS OF TREATMENT OR FINDINGS."

  Patient problems: Failure to Anastomose

  MAUDE report 11693343 ↗
• MalfunctionAug 26, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN EXLCP SIGMOID COLON RESECTION STAPLER MISFIRED ONLY A FEW STAPLES CAME OUT WHEN FIRED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454027 ↗
• MalfunctionOct 21, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE STAPLE LINE ON THE DISTAL PART DIDN'T HOLD: THE STAPLES DID NOT CLOSED. ANASTOMOSIS HAS BEEN PERFORMED WITH A SUTURE. EXTENSION OF THE PROCEDURE TIME (60 MINUTES).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213448 ↗
• MalfunctionJul 26, 2019Fitting Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE RELOAD WOULD NOT FIT. THE STAPLER WOULDN'T FIRE. 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 8833600 ↗
• InjuryJun 28, 2019Failure to Deliver; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE SURGEON SAID THAT AFTER HE FIRED THE STAPLER HE WENT TO OPEN THE STAPLER BY ¿PRESSING THE BUTTON ON THE BACK¿. SURGICAL PROCEDURE WAS A ¿LARGE ABDOMINAL CASE¿. THE STAPLER WAS FIRED ON THE PANCREAS. NO ISSUES WERE NOTED IN REGARDS TO STAPLE FORM IN THE INITIAL SURGICAL PROCEDURE. SURGEON BELIEVES THAT THE STAPLES NEVER FIRED AND THAT THE COMPRESSION MAY HAVE HELD THE TISSUE TOGETHER INTRAOPERATIVELY. IT IS UNKNOWN IF THE DEVICE WAS FIRED PREVIOUSLY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WENT TO ICU. PATIENT PRESENTED WITH BLEEDING AND CAME BACK TO THE OR FOR REOPERATION. SURGEON REVIEWED THE LINE IN THE REOP AND ALLEGES THERE WERE NOT STAPLES IN THE AREA WHERE IT WAS USED.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8745864 ↗
• MalfunctionMar 15, 2019Failure to Form Staple; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY PROCEDURE THAT WHILE TRYING TO STAPLE THEY CLOSED THE HANDLE AND NO STAPLES WERE DEPLOYED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGEON STATED THAT SHE MAY HAVE CLOSED THE HANDLE PRIOR TO POSITIONING THE DEVICE AND MAY HAVE FIRED THE DEVICE PRIOR TO THE INTENDED USE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424852 ↗
• MalfunctionMar 8, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PART OF CLOSING HANDLE CAN'T BE LOCKED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403579 ↗
• MalfunctionFeb 20, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING A HARTMAN PROCEDURE, AFTER THE MACHINE HAD BEEN FIRED, HALF OF THE STAPLE LINE HAD THE STAPLES OPEN. THE STAPLES WERE OPEN IN HALF OF THE STAPLE LINE. SUTURE WAS USED TO ADDRESS THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354415 ↗
• MalfunctionDec 9, 2018Failure to Form Staple

  IT WAS REPORTED THE WHEN IT USED IN CASE OF RIGHT HEMICOLECTOMY, 1/3 OF STAPLE DID NOT GET THE STICK ON THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8145299 ↗
• MalfunctionAug 20, 2018Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLER FIRED AND THE STAPLES DIDN'T GO INTO THE TISSUE, THEY GOT A RELOAD AND IT JAMMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797583 ↗
• MalfunctionAug 2, 2018Firing Problem

  IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, STAPLER DID NOT FIRE STAPLES DURING SMALL BOWEL RESECTION, FISTULA TAKE DOWN AND REPAIR OF ENTEROTOMY WITH SURGEON. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7742503 ↗
• InjuryApr 10, 2018Leak/Splash

  IT WAS REPORTED THAT DURING AN ILEOSTOMY PROCEDURE, THE SURGEON EXPERIENCED AN ANASTOMOTIC LEAK. THE PATIENT WAS GETTING SEPTIC; RETURNED TO OPERATING ROOM FOR RE-EXPLORATION. UPON RE-EXPLORATION, LEAKAGE WAS NOTED FROM THE DEVICE'S STAPLE LINE. ILEOSTOMY CLOSURE.

  Patient problems: No Code Available

  MAUDE report 7416760 ↗
• InjuryApr 10, 2018Leak/Splash; Failure to Form Staple

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED AN ANASTOMOTIC LEAK WHERE THE DEVICE WAS USED. ON RE-EXPLORATION IT WAS NOTED THAT THE STAPLE LINE HAD AN OBVIOUS DEFECT.

  Patient problems: No Code Available

  MAUDE report 7416304 ↗
• MalfunctionFeb 8, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A BOWEL RESECTION THE STAPLE LINE DIDN'T HOLD CLOSED. A COMPETITIVE STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO PRODUCT WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7252092 ↗
• MalfunctionDec 12, 2017Break

  IT WAS REPORTED, THAT DURING A BOWEL ANASTOMOSIS, WHEN THE KNOB IS TURNED ON DEVICE, BODY OF STAPLER SPLITS AND BREAKS. BREAKAGE OCCURRED DURING CASE, PRIOR TO PERFORMING BOWEL ANASTOMOSIS. PATIENTS OUTCOME FINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7110072 ↗