MalfunctionOLL

ENT SINUS

Received Feb 4, 2020 · Event occurred Dec 16, 2019

Report 9664356 · MDR key 9664356

Device

Generic name

Septal Stapler/absorbable Staples

Manufacturer

Smith & Nephew, Inc.

Catalog number

601-00100

Lot number

01908004

Product problems

Break

Patient

7300 DA

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

HANDPIECE OF SEPTAL STAPLER CAME APART INTO TWO PIECES DURING A SURGICAL PROCEDURE FOR SEPTOPLASTY. DID NOT INJURE THE PATIENT. POTENTIAL FOR PERFORATION.