MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemostasis (1895); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.Date of event: publication year of 2013.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.No further information will be provided, because we can¿t get any additional information from the customer.

Event Description

Title: totally thoracoscopic surgery and troubleshooting for bleeding in non-small cell lung cancer author: shin-ichi yamashita, md, phd, keita tokuishi, md, phd, toshihiko moroga, md, phd, sosei abe, md, kozo yamamoto, md, so miyahara, md, yasuhiro yoshida, md, phd, jun yanagisawa, md, phd, daisuke hamatake, md, masafumi hiratsuka, md, phd, yasuteru yoshinaga, md, phd, satoshi yamamoto, md, phd, takeshi shiraishi, md, phd, katsunobu kawahara, md, phd, and akinori iwasakai, md, phd.Citation: ann thorac surg 2013;95:994-999.The aim of this retrospective study was to evaluate intraoperative vessel injury and troubleshooting to ensure the feasibility and safety of video-assisted thoracic surgery (vats) anatomic lung resection.From january 2004 to december 2011, a total of 26 intraoperative vessel injuries (n=13 males and n=13 females, median age: 71 years, age range: 55-84) requiring manipulation for hemostasis, additional thoracotomy, or blood transfusion were identified.The intrathoracic procedure for hilar and intralobar artery involved division using scissors or forceps, and ligation or stapling first, after pulmonary vein ligation, stapling, or bronchus stapling.After extirpation of resected lung, procedures were followed by systemic mediastinal lymph node dissection.Energy devices including ultrasonic coagulation shears, harmonic scalpel (ethicon), ligasure, or enseal tissue sealing devices (ethicon) were used as per individual surgeons¿ preferences.Complaint included intraoperative vessel injury (n=?), and bleeding (n=?).Treatment was primary closure or sealant, or in cases of more serious bleeding, the port site should be enlarged as soon as possible after applying the gauze tamponade.Vascular clamps were applied to control massive bleeding if applicable, and suturing was performed with 5-0 or 6-0 prolene (ethicon).In conclusion, video-assisted thoracic surgery anatomic resection was feasible and safe, regardless of the intraoperative vessel injury.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9604412
• MDR Text Key: 188685868
• Report Number: 3005075853-2020-00463
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other