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 Stroke/CVA (1770); Cerebrospinal Fluid Leakage (1772); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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: acta neurochirurgica (2021) 163:2269¿2277,https://doi.Org/10.1007/s00701-020-04694-y.Event related to mw# 2210968-2021-08488.

Event Description

It was reported via a journal article: title: clinical applications of the endoscopic transorbital approach for various lesions.Authors: jihwan yoo, hun ho park, in-sik yun,chang-ki hong.Citation: acta neurochirurgica (2021) 163:2269¿2277,https://doi.Org/10.1007/s00701-020-04694-y.From june 2017 to march 2019, the surgeons conducted etoas via the superior eyelid crease in 22 patients for the treatment of lesions confined to the middle fossa with and without slight extension to the posterior fossa.These lesions included 5 gliomas, 11 meningiomas, 3 schwannomas, 1 lymphoma, 1 cavernous hemangioma in the orbital wall, and 1 hemangiopericytoma mimicking schwannoma.Perioperative radiologic findings and clinical outcomes were recorded.The tumor margins were secured and detached with a hemostatic sheet (surgicel®, ethicon, oh, usa) and removed with an ultrasonic aspirator.Finally, the skin closed with 6-0 nylon sutures(ethicon).Reported complications included ocular csf leaks in meningioma and glioma (n=2), transient eom dysfunction(n=4), the glioblastoma patient suffered from ischemic stroke in the posterior cerebral artery.The hemangiopericytoma patient had high tumor vascularity.In conclusion the endoscopic transorbital approach could be considered to be feasible for various lesions with different characteristics.After carefully considering the lesion anatomy, consistency, and vascular relationships, using this approach, we could achieve a satisfactory extent of resection without severe complications.

• 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: 12478638
• MDR Text Key: 272217807
• Report Number: 2210968-2021-08489
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/08/2021

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: 09/08/2021
• Initial Date FDA Received: 09/15/2021
• 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