MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH PDS II; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EZ10G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion code: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent a video-assisted thoracoscopic left upper lobectomy procedure on (b)(6) 2016 and suture was used on the branching root of superior pulmonary vein.During the procedure, the superior pulmonary vein was cut off with a stapler, and then the suture was used on the root of the vein.When ligation was performed, the suture was inserted deeply; the knot was placed/shoved deeply though normally the knot would be placed on the tissue surface to avoid contacting other tissues.After the procedure, the patient's bronchial tube was suspected to be perforated.It was also reported no bleeding occurred.The surgeon opined that the shoved knot might have caused the damage to the bronchial tube.The damaged/perforated bronchial tube was found with a bronchoscope on (b)(6) 2016 and the purple substance like the suture was seen from the bronchoscope on (b)(6) 2016.It was reported that the bronchial tube perforation is not closed.The doctor decided to watch and wait because no leak was found.The patient is stable and will get out of the hospital in the near future.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 04/18/2016, it was found by bronchoscopic examinations on (b)(6) 2016 and (b)(6) 2016 that the bronchial tube was perforated by the cut end of the suture.The patient is monitored and will be discharged from the hospital.The doctor opined that there was no problem when suture was used.

• Brand Name: ENDOLOOP LIGATURE WITH PDS II
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5567201
• MDR Text Key: 42330984
• Report Number: 2210968-2016-07929
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EZ10G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention