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

Model Number 0205

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Unfortunately we cannot comment further at this moment in time as we are awaiting a sample to be returned to perform an investigation on.As well as this as we have not been provided any traceable information such as the lot number we cannot perform any traceability investigations for the device in question.We have asked the healthcare facility to clarify point made on their notification.

Event Description

Description given by healthcare facility: "blade broke off inside the patient".We have requested more information from the healthcare facility, e.G., what procedure was being perfomed at the time of breakage.

• Brand Name: SWANN-MORTON
• Type of Device: SCALPEL BLADE, SINGLE USE
• 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: 9109649
• MDR Text Key: 219191587
• Report Number: 9611194-2019-00005
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2019

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: Health Professional
• Device Model Number: 0205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other