MAUDE Adverse Event Report: SWANN MORTON, LTD SWANN MORTON; SINGLE USE SCALPEL BLADE

Model Number 0291

Device Problem Mechanical Problem (1384)

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

Event Date 08/28/2017

Event Type  malfunction  

Event Description

Customer description "two occurrences of swann-morton blades cs00sm11p breaking.One broke on the handle and the other in the patient's knee during the procedure.

• Brand Name: SWANN MORTON
• Type of Device: SINGLE USE SCALPEL BLADE
• Manufacturer (Section D): SWANN MORTON, LTD; owlerton green; sheffield, ; UK
• Manufacturer (Section G): SWANN MORTON, LTD; owlerton green; sheffield, ; UK
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 6916501
• MDR Text Key: 88453303
• Report Number: 9611194-2017-00006
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• 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