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

Catalog Number NSEALXXX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Paralysis (1997); Burn, Thermal (2530); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

Title: unusual complication in thyroid surgery.Case report and literature review author(s): nicola tartaglia, roberta iadarola, alessandra di lascia, alberto fersini, antonioambrosi citation: acta medica mediterranea, 2018, 34: 423; doi: 10.19193/0393-6384_2018_2_66.The authors presented a case of a patient who experienced tracheal perforation during thyroid surgery.From 2006 to 2017, about 2150 total thyroidectomies were performed and a single case of tracheal injury was reported.This patient is a (b)(6) female who underwent elective total thyroidectomy.During the procedure, enseal bipolar device was used for right gruber ligament and immediately after, a thermal damage was found to the anterior-lateral surface of the trachea (i/ii tracheal ring).The tracheal injury was repaired primarily using prolene 3/0 sutures.A muscle flap was used for reinforcement and a suction drains were left at the surgical site.In postoperative day v, the patient underwent bronchoscopy and subsequent tracheostomy because the wound was still open.In postoperative day vii, the patient was readmitted with tracheostomy in spontaneously breathing and with good cardio-pulmonary parameters.The patient was diagnosed with adduction vocal cord paralysis for which she started phonation and swallowing training.In this case, the patient complication was associated with the device used.The use of device like diathermy can be dangerous for tracheal lesion.Tracheal perforation is generally not considered a complication as such, but rather a technical occurrence during surgery that requires expeditious attention.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7625287
• MDR Text Key: 111882524
• Report Number: 3005075853-2018-10832
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention