MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	1951
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.Surg today.1997;27(10):969¿70.
Event or Problem Description
It was reported via a journal article: iwabuchi s, koike k, okabe t, et al.Iatrogenic paraplegia caused by surgicel used for hemostasis during a thoracotomy: report of a case.Surg today.1997;27(10):969¿70.Iwabuchi et al.Reports a case of a patient ((b)(6) yo) that presents with paraplegia, 1 day after a right lower lobectomy.During the surgery the surgeon placed surgicel and bone wax to control bleeding from the 5th intercostal artery.The surgeon cut the surgicel into small pieces and packed the hemostate into the intercostal space.Bone wax was then impacted on top of the surgicel to prevent the surgicel from becoming dislodged.Following the procedure, the patient developed paraplegia below t-5.Mri on pod 1 revealed a shadow mass compressing the spinal cord, initially thought to be a hematoma.The patient was returned to the operating room for an emergency laminectomy where a piece of surgicel posterior to the spinal cord was removed.The patient has since regained much of their motor function lost and can ambulate with the assistance of crutches.

• Brand Name: SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10058062
• Report Number: 2210968-2020-03936
• Device Sequence Number: 3052903
• Product Code: LMG
• UDI-Device Identifier: 10705031003019
• UDI-Public: 10705031003019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1951
• Device Catalogue Number: 1951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR