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 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 (tsb 35/45); leaking areas were treated either by minimal wedge resection or by no-knife stapling (nsb 45, ethicon).Postoperative treatment complication (redo vats) included localized pleural effusion in one patient which resolved with thoracentesis.No recurrences was seen in the overall group.Redo-vats seems to be a promising tool for the surgical therapy of recurrences following vats treatment of primary spontaneous pneumothorax.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8189303
• Report Number: 3005075853-2018-15380
• Device Sequence Number: 1900359
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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: 12/04/2018
• Initial Report FDA Received Date: 12/21/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention