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

Model Number 0391

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

A sample of the broken blade has been requested for further investigation.It was stated by the customer that the sample status is unknown.Furthermore, no sample was provided; therefore, device location is unknown.

Event Description

Blade broke during use.Tip left inside patient, causing trauma to local tissues upon removal.

• Brand Name: SWANN MORTON
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; penn works owlerton green; sheffield, ; UK
• Manufacturer (Section G): SWANN-MORTON LTD; penn works owlerton green; sheffield, ; UK
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 8099810
• MDR Text Key: 128199303
• Report Number: 9611194-2018-00007
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0391
• Device Catalogue Number: 0391
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/23/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention