PROXIMATE TLH30Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705036013228), received between Dec 20, 2017 and May 3, 2023 — classified as 1 death, 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2023Adverse 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: SAFE PNEUMONECTOMY FOR LOCALLY ADVANCED LUNG CANCER AFTER INDUCTION THERAPY . AUTHOR(S): TETSUHIKO GO, TOSHIHIRO IKEDA, NAOYA YOKOTA, ATSUSHI FUJIWARA, YASUHIRO OTSUKI, AYUMU KATO, SUNG SOO CHANG, NORIYUKI MISAKI, DAGE LIU, HIROYASU YOKOMISE . CITATION: SURGERY TODAY (2022) 52:316¿323; HTTPS://DOI.ORG/10.1007/S00595-021-02333-2 . THE PURPOSE OF THE STUDY IS TO ASSESS THE SAFETY AND LONG-TERM OUTCOMES OF PNEUMONECTOMY AFTER INDUCTION THERAPY VERSUS UPFRONT PNEUMONECTOMY WITHOUT INDUCTION THERAPY FOR LOCALLY ADVANCED NON-SMALL-CELL LUNG CANCER. BETWEEN 2000 AND 2019, 69 PATIENTS WITH LOCALLY ADVANCED NON-SMALL-CELL LUNG CANCER WHO UNDERWENT PNEUMONECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 56 MALES AND 13 FEMALES WITH A MEDIAN AGE OF 65 YEARS (RANGE, 44-78 YEARS). 30 PATIENTS UNDERWENT PNEUMONECTOMY WITHOUT INDUCTION THERAPY (U-PN GROUP) WHILE 29 PATIENTS UNDERWENT PNEUMONECTOMY AFTER INDUCTION THERAPY (IT-PN GROUP). THE PATIENTS UNDERWENT PNEUMONECTOMY AND SYSTEMATIC LYMPH NODE DISSECTION. MOST PULMONARY VESSELS WERE STAPLED AND CLOSED. IN MOST CASES, PROXIMATE TLH 30 (ETHICON ENDO-SURGERY) OR ECHELON FLEX (ETHICON ENDO-SURGERY) WERE US

  Patient problems: Fistula

  MAUDE report 16862372 ↗
• DeathMay 3, 2023Adverse 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: SAFE PNEUMONECTOMY FOR LOCALLY ADVANCED LUNG CANCER AFTER INDUCTION THERAPY . AUTHOR(S): TETSUHIKO GO, TOSHIHIRO IKEDA, NAOYA YOKOTA, ATSUSHI FUJIWARA, YASUHIRO OTSUKI, AYUMU KATO, SUNG SOO CHANG, NORIYUKI MISAKI, DAGE LIU, HIROYASU YOKOMISE . CITATION: SURGERY TODAY (2022) 52:316¿323; HTTPS://DOI.ORG/10.1007/S00595-021-02333-2 . THE PURPOSE OF THE STUDY IS TO ASSESS THE SAFETY AND LONG-TERM OUTCOMES OF PNEUMONECTOMY AFTER INDUCTION THERAPY VERSUS UPFRONT PNEUMONECTOMY WITHOUT INDUCTION THERAPY FOR LOCALLY ADVANCED NON-SMALL-CELL LUNG CANCER. BETWEEN 2000 AND 2019, 69 PATIENTS WITH LOCALLY ADVANCED NON-SMALL-CELL LUNG CANCER WHO UNDERWENT PNEUMONECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 56 MALES AND 13 FEMALES WITH A MEDIAN AGE OF 65 YEARS (RANGE, 44-78 YEARS). 30 PATIENTS UNDERWENT PNEUMONECTOMY WITHOUT INDUCTION THERAPY (U-PN GROUP) WHILE 29 PATIENTS UNDERWENT PNEUMONECTOMY AFTER INDUCTION THERAPY (IT-PN GROUP). THE PATIENTS UNDERWENT PNEUMONECTOMY AND SYSTEMATIC LYMPH NODE DISSECTION. MOST PULMONARY VESSELS WERE STAPLED AND CLOSED. IN MOST CASES, PROXIMATE TLH 30 (ETHICON ENDO-SURGERY) OR ECHELON FLEX (ETHICON ENDO-SURGERY) WERE US

  Patient problems: Fistula; Pneumonia

  MAUDE report 16862270 ↗
• InjuryApr 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: INTERCOSTAL DRAIN MIGRATION POST ESOPHAGECTOMY. AUTHOR : J. A. GOSSAGE, A. O. CHUKWUEMEKA, J. E. DUSSEK. CITATION: DISEASES OF THE ESOPHAGUS (2003) 16, 268¿269. THE PLACEMENT OF AN INTERCOSTAL DRAIN IS ROUTINE AFTER A THORACOTOMY. THE DRAIN WILL BE REMOVED WHEN THE DRAINAGE HAS CEASED, THERE IS NO AIR LEAK AND THE LUNG HAS FULLY EXPANDED. THE EROSION OF AN INTERCOSTAL DRAIN INTO THE STOMACH CAVITY AFTER AN ELECTIVE ESOPHAGECTOMY HAS NOT BEEN REPORTED BEFORE. REPORTED COMPLICATIONS INCLUDED : A CASE OF A 38-YEAR-OLD MAN WITH A TUMOR OF THE DISTAL THIRD OF THE ESOPHAGUS AND SUBSEQUENT BIOPSIES CONFIRMED A SQUAMOUS CELL CARCINOMA UNDERWENT AN IVOR¿LEWIS ESOPHAGECTOMY.THE LESSER CURVATURE WAS CLOSED USING A PROXIMATE TLH30 (JOHNSON AND JOHNSON, BRACKNELL BERKS., UK) RELOADABLE LINEAR STAPLER AND THE FREE END OF THE ESOPHAGUS ANASTOMOSED TO THE STOMACH REMNANT USING CONTINUOUS 3.0 POLYDIOXANONE.A SINGLE INTERCOSTAL DRAIN WAS PLACED IN THE PARAVERTEBRAL GUTTER UNDER DIRECT VISION.ON THE FIFTH DAY THERE WAS A LARGE INCREASE IN DRAINAGE VOLUME. 1250 ML OF CLOUDY BROWN FLUID DRAINED FROM THE RIGHT PLEURAL SPACE. THE PATIENT HAD INCREASED TENDERNES

  Patient problems: Insufficient Information

  MAUDE report 11752397 ↗
• MalfunctionMar 5, 2020Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON OPENED THE PACKAGING AND NOTED THAT THERE WAS CARTRIDGE RETENTION. THE SURGEON DID NOT USE IT ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793524 ↗
• MalfunctionJan 16, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN PNEUMONECTOMY OF LEFT LUNG, MOST OF THE DEPLOYED STAPLES WERE NOT FORMED PROPERLY AT THE FIRST FIRING ON THE LEFT MAIN BRONCHUS. THOSE WERE BARELY STUCK ON THE TISSUE AND THE DEPLOYED STAPLES WERE U-SHAPED THE ISSUE WAS RECOGNIZED WHEN THE BRONCHIAL TUBE OF THE SPECIMEN SIDE WAS CUT AFTER THE FIRST FIRING. ADDITIONAL SUTURE WAS PERFORMED WITH PDS TO COMPLETE THE CASE, AND NO PROBLEM WAS OBSERVED AT A LEAK TEST. NO LEAK OCCURRED WHEN THE STAPLES WERE DEPLOYED IN U-SHAPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596823 ↗
• MalfunctionJan 15, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING A LUNG CANCER SURGERY, WHEN SEVERING THE BRONCHUS, IT WAS NOTED THAT THE STAPLES WERE MALFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590528 ↗
• MalfunctionJan 13, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING A PNEUMONECTOMY PROCEDURE, THE STAPLES WERE NOT DEPLOYED AT THE FIRING ON THE BRONCHIAL TUBE. IT WAS FOUND THAT THE STAPLES WERE SCATTERED ON THE MAYO TABLE. THERE WAS NO BLEEDING AND LEAKAGE FOR THE PATIENT. THE SURGEON SUTURED THE STAPLE LINE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581084 ↗
• MalfunctionNov 22, 2019Difficult to Open or Close; Device Fell

  IT WAS REPORTED THAT DURING THE OPEN LOBOTOMY SURGERY, DID NOT OPEN THE PACKING, NOTED THE CARTRIDGE FELL OFF AS THE PHOTO SHOWS. 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 9364831 ↗
• MalfunctionNov 21, 2019Failure to Form Staple

  MALFORMED STAPLES. IT WAS REPORTED THAT DURING THE OPEN LOBECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 9356025 ↗
• MalfunctionApr 19, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF ESOPHAGEAL CANCER SURGERY, AFTER FIRED, NOTED SOME STAPLES IN THE TISSUE WERE MALFORMED, SOME STAPLES FELL OFF (NOT IN THE TISSUE). CHANGED TO 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 8532582 ↗
• MalfunctionNov 9, 2018Difficult to Open or Close

  IT WAS REPORTED THAT THE JAW COULD NOT OPEN. DURING THE LOBECTOMY, COULD NOT OPEN THE JAW. CUSTOMER CAN'T REMEMBER HOW TO OPEN THE JAW AT LAST. 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 8056252 ↗
• MalfunctionJun 14, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE, THE MOST EXCISION OF OPEN ULCERATION OF GASTRIC ULCER, AFTER FIRED, FOUND NO STAPLE. 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 7602970 ↗
• MalfunctionJun 14, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LOBECTOMY, AFTER FIRED, FOUND SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 7602830 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, BEFORE OPENED THE STERILE PACKING, FOUND THE CARTRIDGE DETACHED FROM THE DEVICE AS THE PHOTO SHOWS. 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 7579755 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE ROLE OF MUSCLE FLAP IN PREVENTING BRONCHUS STUMP INSUFFICIENCY AFTER PNEUMONECTOMY FOR MALIGNANT PLEURAL MESOTHELIOMA IN HIGH-RISK PATIENT AUTHORS: MORRIS BESHAY, GIOVANNI CARBONI, BEATRIX HOKSCH, MARC A. REYMOND, RALPH A. SCHMID CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY. 2008; 7: 621 625. DOI: 10.1510/ICVTS.2007.166546 THE AUTHORS RETROSPECTIVELY ANALYZED ALL PATIENTS WHO UNDERWENT EXTRA PLEURAL PNEUMONECTOMY (EPP) WITH PRIMARY MUSCLE FLAP COVER OF THE BRONCHUS STUMP. A TOTAL OF 30 PATIENTS (AGE RANGE: 40 TO 83 YEARS OLD) WITH MALIGNANT PLEURAL MESOTHELIOMA (MPM) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, ALL PATIENTS RECEIVED A MUSCLE SPARING ANTERO-LATERAL THORACOTOMY. THE HEAVY WIRE LINEAR STAPLER TLH30 WAS USED FOR DIVISION OF THE BRONCHUS. THEREAFTER, LATISSIMUS DORSI MUSCLE OR SERRATUS ANTERIOR MUSCLE WAS USED TO COVER THE BRONCHUS STUMP IN ALL PATIENTS. THE MUSCLE FLAP (MF) IS FIXED ON THE BRONCHUS STUMP IN A SANDWICH TECHNIQUE USING 3 INTERRUPTED PDS II 3-0 SUTURES FROM BEHIND AND IN FRONT. REPORTED COMPLICATIONS INCLUDED HEMORRHAGIC SECRETION (N-2) WHICH REQUIRED THORACIC DRAINAGE TO BE RETAINED AND LO

  Patient problems: No Code Available; Seroma

  MAUDE report 7446373 ↗
• MalfunctionFeb 7, 2018Fluid/Blood Leak; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF LUNG CANCER, WHEN SEVERING THE BRONCHUS, AFTER FIRED, FOUND ONE OF STAPLE LINE WAS MALFORMED WITH IRREGULAR SHAPE. BRONCHUS HAD LEAKAGE, SUTURE WAS USED TO SEW THE WOUND. THE SURGERY DELAYED ABOUT 15 MINUTES. THE PATIENT IS STABLE AND IN HOSPITAL NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247190 ↗
• MalfunctionDec 20, 2017Component Missing

  IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF LUNG CANCER, THE NURSE OPENED THE PACKING, THE SURGEON USED IT TO FIRED, FOUND NO STAPLES, CHECKED THE DEVICE, FOUND THE CARTRIDGE WAS MISSING. SUTURE WAS USED TO SEW THE WOUND. X LIGHT WAS TAKEN TO FIND NO CARTRIDGE OR REMNANTS OF THE PATIENT'S CHEST. THE SURGERY DELAYED ABOUT 1.5 HOURS. THE PATIENT IS STABLE IN HOSPITAL NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133788 ↗