ENDOPATH TSB35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705036013355), received between Dec 21, 2018 and Jan 2, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2019Insufficient Device Problem Information

  IT WAS REPORTED THROUGH JOURNAL ARTICLE: TITLE: "VIDEOTHORACOSCOPIC TREATMENT OF PRIMARY SPONTANEOUS PNEUMOTHORAX: A 6-YEAR EXPERIENCE." AUTHORS: GIUSEPPE CARDILLO, MD, FRANCESCO FACCIOLO, MD, ROBERTO GIUNTI, MD, ROBERTO GASPARRI, MD, MICHELE LOPERGOLO, MD, REMO ORSETTI, MD, AND MASSIMO MARTELLI, MD. CITATION: ANN THORAC SURG 2000; 69:357¿ 62. FROM JULY 1, 1992, TO MAY 1, 1998, OF 1,307 VIDEO-ASSISTED THORACIC SURGERY (VATS) PROCEDURES PERFORMED AT THE DEPARTMENT OF THORACIC SURGERY, FORLANINI HOSPITAL IN ROME, 432 PATIENTS (33.1%) UNDERWENT VATS TREATMENT OF PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP). ALL PROCEDURES WERE PERFORMED WITH THE PATIENT UNDER GENERAL ANESTHESIA AND ONE LUNG VENTILATION. THE PATIENT WAS PLACED IN THE LATERAL POSITION WITH THE ARM HELD ABDUCTED TO ALLOW MAXIMUM SUPERIOR DISPLACEMENT OF THE SCAPULA. DURING THE TALC POUDRAGE PROCEDURE, WITH REGARDS THE TREATMENT OF THE BULLAE, IT INCLUDED ALWAYS GRASPING AT THE BASE TOGETHER WITH HEALTHY TISSUE; IN STAGE III, BULLAE WERE LIGATED WITH A 0 OR 00 COATED VICRYL ROEDER LOOP (ENDOLOOP EJ 10G, ETHICON INC, SOMERVILLE, NJ) OR TREATED BY MINIMAL WEDGE RESECTION WITH THE ENDOSCOPIC STAPLER (TSB 35, ETHICON ENDOSURGERY, C

  Patient problems: No Code Available; Pleural Effusion

  MAUDE report 8209322 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN JOURNAL ARTICLE: TITLE: "RECURRENCES FOLLOWING VIDEOTHORACOSCOPIC TREATMENT OF PRIMARY SPONTANEOUS PNEUMOTHORAX: THE ROLE OF REDO-VIDEOTHORACOSCOPY", AUTHOR(S): GIUSEPPE CARDILLOA, FRANCESCO FACCIOLOA, MOHAMED REGALA, LUIGI CARBONEA, FELICITA CORZANIA, ALBERTO RICCIB, MASSIMO MARTELLIA, CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 19 (2001) 396-399. THIS STUDY AIMED TO DETERMINE THE FEASIBILITY AND THE RESULTS OF 19 RE-DO VIDEO-ASSISTED THORACIC SURGERY (VATS) PERFORMED IN A GROUP OF 27 PATIENTS TREATED BECAUSE OF RECURRENCES FOLLOWING VATS TREATMENT OF PRIMARY SPONTANEOUS PNEUMOTHORAX. FROM 01JUL1992 TO 01SEP2000, 597 PATIENTS UNDERWENT VATS FOR THE TREATMENT OF PRIMARY SPONTANEOUS PNEUMOTHORAX. IN THIS PATIENTS, THE TREATMENT OF BULLAE INCLUDED LIGATION OF THE BULLAE WITH A 0 OR 00 COATED VICRYL ROEDER LOOP (ENDOLOOP EJ 10 G) OR MINIMAL WEDGE RESECTION WITH ENDOSCOPIC STAPLER (TSB 35, ETHICON). AT A MEAN FOLLOW-UP OF 33 MONTHS, 27 PATIENTS HAD RECURRENCES FOR WHICH WERE TREATED WITH REDO-VATS (N=19), THORACOTOMY (N=4), PLEURAL DRAINAGE (N=3) AND BED REST (N=1). IN REDO VATS, RESIDUAL BULLAE WAS TREATED BY MINIMAL WEDGE RESECTION WITH ENDOSCOPIC STAPLER

  Patient problems: No Code Available; Pleural Effusion

  MAUDE report 8189303 ↗