MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Distress (2045); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: world journal of surgical oncology (2018) 16:74; doi: https://doi.Org/10.1186/s12957-018-1374-x (b)(4).

Event Description

It was reported via journal article title : robotic sleeve resection for pulmonary disease author : chengqiang li, bin zhou, yu han, runsen jin, jie xiang and hecheng li citation: world journal of surgical oncology (2018) 16:74; doi: https://doi.Org/10.1186/s12957-018-1374-x this study aimed to report successful implementation of a completely portal robotic sleeve resection with or without pulmonary resection using a modified suture mode.From may2015 to sep2017, 339 patients underwent curative robotic pulmonary surgery where 3 patients (all male) underwent sleeve resection.In robotic sleeve resection, a double-armed 3-0 prolene suture was used to performed end-to-end bronchial anastomosis using a simple running suture combined with two interrupted sutures of the membranous and cartilaginous junction parts.The side of the upper segment of the trachea was narrowed to better match the calibre of the distal segmental bronchus with 5-0 prolene.Narrow the rim of left upper lobe bronchus to better match the calibre of the distal segment bronchus with a 5-0 prolene.End-to-side bronchial anastomosis was performed by a 5-0 pds ii continuous running suture.Postoperatively, a (b)(6) male patient who had left lingular segment resection developed short-term atelectasis which was treated with bronchoscope sputum suction and antibiotic treatment and achieved full re-expansion of the lingular segment during follow-up.This study suggested that robotic sleeve resection for pulmonary disease with or without pulmonary resection may be safe and effective.The anastomosis time can be shortened with more robotic surgery experiences and the modified suture mode.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7671102
• MDR Text Key: 113511787
• Report Number: 2210968-2018-74190
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR