PROXIMATE TLH90Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036013242), received between Feb 1, 2018 and Nov 25, 2019 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY THE DEVICE CUT BUT DIDN'T STAPLE. THE DOCTOR HAND SEWED THE COLON. A SECOND DEVICE WAS NOT USED IN THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369157 ↗
• InjuryOct 11, 2019Leak/Splash

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A RIGHT COLECTOMY ON A PATIENT, USING A TLH90, ON (B)(6) 2019. THE PATIENT RETURNED ON (B)(6) 2019, WITH AN ANASTOMOTIC LEAK. THE DOCTOR OPERATED ON THE PATIENT TO RESOLVE THE LEAK. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9180421 ↗
• MalfunctionOct 11, 2019Failure to Form Staple

  MALFORMED STAPLES. IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF RECTAL CANCER, AFTER FIRED, NOTED STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179955 ↗
• MalfunctionDec 3, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, STAPLES MALFORMED. DURING THE OPEN RECTUM, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 8126292 ↗
• MalfunctionJul 26, 2018Firing Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY HARTMAN PROCEDURE, ¿INTRAOPERATIVELY STAPLER WOULD NOT PROPERLY FIRE ACROSS THE BOWEL. SURGEON USED SUTURE TO CLOSE THE RECTAL STUMP. SUTURE LINE WAS INSPECTED AND NOTED TO BE INTACT AND HEMOSTATIC.¿ NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7722883 ↗
• MalfunctionFeb 21, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A PARTIAL OPEN GASTRECTOMY PROCEDURE THE DEVICE WAS PLACED ON TISSUE, FIRED, BUT STAPLES WERE UNFORMED, GOAL POST. TOWARDS THE BASE OF THE ANVIL THEY WERE PARTIALLY FORMED. THE PROCEDURE WAS COMPLETED BY SUTURING THE TISSUE. IT WAS UNKNOWN IF THE STAPLES HAD BEEN REMOVED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286037 ↗
• MalfunctionFeb 14, 2018Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DOCTOR TRIED TO OPEN THE JAWS WITH THE ROUND TIP ON THE BACK OF THE INSTRUMENT, BUT THE JAWS REMAINED STABLE. THE DOCTOR REQUESTED ANOTHER SAME DEVICE AND PROCEDURE WAS CARRIED OUT WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269395 ↗
• MalfunctionFeb 1, 2018Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A GENERAL OPEN PROCEDURE THE DEVICE MISFIRED AND DID NOT STAPLE. NO ADDITIONAL DETAILS WERE AVAILABLE. THE CUSTOMER WAS USING A YELLOW RELOAD. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7234033 ↗