MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

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

Patient Problems Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Health effect - clinical code: (b)(4) recurrence of bullae.Component code: (b)(4) device not returned.This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot 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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Can you identify the product code and lot number of the product that was used in each procedure? can specific patient demographics initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? citation: general thoracic and cardiovascular surgery (2020) 68:1412¿1417.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via a journal article: title: clinicopathological significance of staple line coverage with an oxidized regenerated cellulose sheet after bullectomy for primary spontaneous pneumothorax.Authors:shunichi nagata, ryo miyata, mitsugu omasa, kosuke tokushige, takao nakanishi, hideki motoyama.Citation: general thoracic and cardiovascular surgery (2020) 68:1412¿1417.Https://doi.Org/10.1007/s11748-020-01393-4.From january 2008 to december 2016, 202 consecutive patients aged < 40 years underwent vats bullectomy as primary surgery for psp.This study included 180 male and 21 female patients, with a median age of 21 years (range 13¿39 years).All patients underwent general anesthesia with intubation of a double-lumen endotracheal tube.A three-port thoracoscopic technique was used.After inspecting the entire visceral pleural surface, bullae and blebs were resected using an endoscopic stapling device.From 2008 to 2013, 101 patients underwent only bullectomy.From 2014 to 2016, lungs > 2 cm around the stapler line after bullectomy were covered with an orc sheet ( surgicel® original absorbable hemostat, 2 × 3 in.; johnson & johnson) in 100 patients.There were no additional treatments such as chemical pleurodesis and pleural abrasion performed during or after surgery.Reported complications included recurrence of bulla within 2 years after surgery (n=11), white pleural thickening within the covered area was observed in all patients of the oxidized regenerated cellulose group.In conclusion coverage with an orc sheet after bullectomy did not prevent the regeneration of bullae and postoperative recurrence, regardless of exerting a reinforcement effect on the visceral pleura histologically.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12492821
• MDR Text Key: 272653294
• Report Number: 2210968-2021-08643
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N12159
• 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
• Report Date: 08/24/2021

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: 08/24/2021
• Initial Date FDA Received: 09/17/2021
• 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