MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RIB-BACK CARBON STEEL SURGICAL BLADE; BLADE, SCALPEL

Catalog Number 0086

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  Injury  

Event Description

A #10 scalpel blade was used for initial skin incision during a cesarean section and immediately placed into the sharps box on the back table.Upon review of the sharps box, it was discovered that the tip of the scalpel had broken off.The surgeon, was notified and an immediate search of the room was initiated with xray ordered.Surgeon was confident that the blade was intact when she used it for the skin incision, and that the tip was also not in the abdomen.The patient was then closed.A magnet was used to try to find the piece in the area surrounding the patient and over the sponges, etc and a floor magnet roller was used for the floor.The tip was not found.The xray report showed 2 clips from prior appendectomy, but no blade tip.The patient was educated that the tip had broken off but all precautions were taken to ensure the tip was not inside.The tip was not found despite all attempts.Staff sequestered the blade and plan to return to the vendor.Pictures of the blade and packaging were also taken.Fda safety report id# (b)(4).

• Brand Name: RIB-BACK CARBON STEEL SURGICAL BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.
• MDR Report Key: 10436410
• MDR Text Key: 204195282
• Report Number: MW5096170
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0086
• Device Lot Number: 0223350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR