MAUDE Adverse Event Report: SWANN-MORTON LTD SWANN MORTON; SCALPEL BLADE

Model Number 0391

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/07/2018

Event Type  malfunction  

Event Description

Description given by healthcare facility: "blade broke into the patient shoulder.Need the incision a bit longer.No injury for the patient.".

• Brand Name: SWANN MORTON
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer (Section G): SWANN-MORTON LTD; penn works owlerton green; sheffield, S6 2B J; UK S6 2BJ
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 7621605
• MDR Text Key: 112162704
• Report Number: 9611194-2018-00003
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0391
• Device Catalogue Number: 0391
• Device Lot Number: 4411608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1