MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pneumothorax (2012)

Event Date 01/02/2021

Event Type  Injury  

Event Description

It was reported via journal article: title: polyglycolic acid mesh for preventing post-thoracoscopic bullectomy recurrence.Authors: eiji miyahara, daisuke ueda, yukari kawasaki, yasutomo ojima, atsuo kimura, tsuneo okumichi.Citation cite: surgery today (2021) 51:971¿977 https://doi.Org/10.1007/s00595-020-02191-4.This retrospective study compared the recurrence rate of pneumothorax following conventional thoracoscopic bullectomy to that following bullectomy using a low-density polyglycolic acid mesh to cover the staple line.Group a comprised 237 patients who experienced 294 episodes of pneumothorax and underwent thoracoscopic bullectomy alone, and group b comprised 130 patients who experienced 155 episodes of pneumothorax and underwent bullectomy with polyglycolic acid mesh used to cover the visceral pleura.To compare the postoperative inflammatory response between the two groups, the surgeons measured three inflammatory parameters: highest body temperature after surgery, c-reactive protein level on postoperative day 3, and change in eosinophil count from the day before the surgery to postoperative day 3.Endopath stapler.[johnson & johnson, new brunswick, nj, usa] was used in group a.Reported complications included postoperative recurrent pneumothorax (n=47) and inflammatory, prolonged air leakage, new bullae.In conclusion using a polyglycolic acid mesh covering after thoracoscopic bullectomy resulted in acceptable long-term results (recurrence rate: 2.6%).This method was associated with a slightly elevated inflammatory response.

Manufacturer Narrative

(b)(4).Batch # unknown.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/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13505229
• MDR Text Key: 288579385
• Report Number: 3005075853-2022-00754
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• 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: 02/10/2022

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
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1