PROXIMATE TL30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036013167), received between Feb 21, 2018 and Apr 30, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: POSTOPERATIVE FUNCTIONAL OUTCOMES AND COMPLICATIONS OF PARTIALLY INTRAANAL CANAL ANASTOMOSIS IN STAPLED ILEAL POUCH ANAL ANASTOMOSIS FOR ULCERATIVE COLITIS AUTHOR: AKIRA SUGITA & KAZUTAKA KOGANEI & KENJI TATSUMI & RYO FUTATSUKI & HIROSUKE KUROKI & KYOKO YAMADA & HIDEAKI KIMURA & TSUNEO FUKUSHIMA CITATION: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2019) 34:1317¿1323 HTTPS://DOI.ORG/10.1007/S00384-019-03322-1 THIS RETROSPECTIVE STUDY AIMED TO COMPARE THE POSTOPERATIVE BOWEL FUNCTION AND COMPLICATIONS OF PICA (PARTIALLY INTRAANAL CANAL ANASTOMOSIS) WITH THOSE OF DS-IPAA (DOUBLE STAPLING TECHNIQUE ILEAL POUCH ANAL ANASTOMOSIS) AFTER 1 YEAR. BETWEEN FEBRUARY 1994 AND DECEMBER 2006 A TOTAL OF 211 ULCERATIVE COLITIS CASES THAT UNDERWENT DS-IPAA, 146 CASES (69%) WITH PICA WHO WERE CONFIRMED BY THE SQUAMOUS EPITHELIUM ON THE POSTERIOR PART OF THE DISTAL DONUTS WERE INCLUDED. SIXTY-FIVE CASES WITH ANASTOMOSIS ABOVE THE ANAL CANAL WERE EVALUATED AS THE CONTROL (DST). ONE STAGE SURGERY UNDERWENT IN 95% OF PICA AND 93% OF CONTROL. DISSECTION OF PERIRECTAL TISSUE TOWARDS THE ANAL CANAL IN THE PELVIC CAVITY WAS REQUIRED TO PERFORM ANASTOMOSIS ON THIS

  Patient problems: Failure to Anastomose

  MAUDE report 11752838 ↗
• MalfunctionSep 28, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT MAKE A STAPLE FORMATION, SO THE CUSTOMER CHANGED A RELOAD, THEN NEW RELOAD MADE A GOOD STAPLE FORMATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917962 ↗
• MalfunctionAug 13, 2018Firing Problem

  IT WAS REPORTED THAT DURING A RETOSIGMOIDECTOMY PROCEDURE, DURING HANDLING OF THE STAPLER, THERE WAS EXTRUSION AND RELEASE OF THE CLAMPS BEFORE THE DRIVE, METHOD BY WHICH WE REQUESTED NEW STAPLER IN ORDER TO FINISH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776597 ↗
• MalfunctionFeb 21, 2018Misfire; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES MISFIRED. IT IS UNKNOWN IF IT WAS USER ERROR. ANOTHER STAPLER WAS USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285491 ↗