MAUDE Adverse Event Report: SWANN MORTON, LTD. CARBON STEEL BLADE BLADE, SCALPEL

Model Number D6201

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ( (b)(4)) was received regarding a scalpel (part d6201, lot 5321812) breaking during use. The investigation is ongoing at this time. When new and critical information becomes available, the report will be updated.

Event Description

The blades are breaking, some inside patients.

• Brand Name: CARBON STEEL BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): SWANN MORTON, LTD.; owlerton green; sheffield, sheffield ; UK
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 11195093
• MDR Text Key: 245731341
• Report Number: 1060680-2020-00009
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: D6201
• Device Lot Number: 5321812
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2020
• 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: Initial