MAUDE Adverse Event Report: ANSELL SANDEL MEDICAL SOLUTIONS LLC WEIGHTED SAFETY SCALPEL

Catalog Number 2210-NSS

Device Problem Mechanical Jam (2983)

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

Event Date 12/15/2013

Event Type  malfunction  

Event Description

Reporter stated that after a surgical procedure was completed, a surgical tech was cleaning up the area when she had some difficulty closing the scalpel.Her glove became caught on the button that slides, causing her hand to slip.When this occurred, the tip of the blade stabbed her other hand.The surgical tech received first aid only since the surgery pt was low risk.Medical treatment was not necessary.

Manufacturer Narrative

No medical intervention was required.Cut finger was cleaned, first aid applied only.Product is not being returned for eval.In accordance with 21 cfr 803.56, if we obtain add'l info which was not known or was not available when the initial report will be submitted to fda.

• Brand Name: WEIGHTED SAFETY SCALPEL
• Type of Device: SAFETY SCALPEL
• Manufacturer (Section D): ANSELL SANDEL MEDICAL SOLUTIONS LLC; 19736 dearborn street; chatsworth CA 91311
• Manufacturer Contact: shelley arnold ; 19736 dearborn street; chatsworth, CA 91311 ; 8185342500
• MDR Report Key: 3711319
• MDR Text Key: 4336030
• Report Number: 3004125670-2014-00001
• Device Sequence Number: 1
• Product Code: GDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2210-NSS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other