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

Model Number 3991

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 04/17/2018

Event Type  Injury  

Event Description

A physican cut himself by trying to close a scalpel.

• Brand Name: TEXTKNIFE
• Type of Device: SCALPEL
• 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: 7599569
• MDR Text Key: 111003102
• Report Number: 9611194-2018-00002
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3991
• Device Catalogue Number: 3991
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other