MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*35 ENDO LINEAR CUTTER BL; STAPLE, IMPLANTABLE

Catalog Number	TSB35
Health Effect - Clinical Codes	Pleural Effusion (2010); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.
Event or Problem Description
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, cincinnati, oh).At the end of the surgical procedure, usually one drain (28 french gauge) was placed through the existing incisions under endoscopic control with a blunt guide.If the water-seal revealed a major air leak, the lung is routinely reinspected by telescope (water-seal test).Postoperative complication rate was 4.16% (18 of 432); it included 4 cases of subcutaneous emphysema, 5 cases of localized pleural effusions, 6 prolonged air leaks (.5 days), 1 minimal pleural detachment, 1 transient bernard-horner syndrome.One localized pleural effusion occurred after isolate talc poudrage.Pleural effusion was treated by thoracentesis.The transient bernard-horner syndrome occurred after monopolar coagulation of apical pleuropulmonary adhesions.Prolonged air leaks occurred after ligation of the bullae (4 cases) and after stapling of the bullae (2 cases, stage iv).They resolved spontaneously.Subcutaneous emphysema occurred at the beginning of our experience: 3 cases following ligation of the bullae and 1 case following stapling of the bullae.Minimal apical pleural detachment occurred 3 days after isolate talc poudrage and resolved spontaneously.Recurrences occurred in 10 cases (52.6%) within 1 year from surgery.At 2 years from surgery, 84.2% of recurrences (16 cases) were present.Recurrences were treated by re-vats (12 patients), standard thoracotomy (3 patients), chest drainage (3 patients), and observation (1 patient).In conclusion, in a first episode of psp, pleural drainage represents the standard treatment; in case of bilateral simultaneous pneumothorax, we suggest pleural drainage and contralateral vats treatment (because of the high morbidity of bilateral simultaneous recurrence).Vats becomes our treatment of choice in patients with spontaneous hemo-pneumothorax, in patients with first episode of psp and previous contralateral pneumothorax, in patients whose professions put them at risk (pilots, scuba divers, sportsmen), in patients with treatment failure of a first episode of psp, and in patients with recurrent sp.In recurrences following vats, we believe that redo-vats will probably represent the treatment of choice, even if, up to the present time, there has been very little experience with this treatment.A minimum 2-year follow-up is necessary for the evaluation of the results.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8209322
• Report Number: 3005075853-2019-15435
• Device Sequence Number: 16830680
• Product Code: GDW
• UDI-Device Identifier: 10705036013358
• UDI-Public: 10705036013358
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TSB35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention