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

Model Number 0291

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

The size 11 blade broke off inside a patient.They were able to retrieve the broken piece but did not save it.The date of occurrence was not known by cardinal health.

• 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: 8234095
• MDR Text Key: 132786259
• Report Number: 9611194-2019-00002
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/09/2019

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: 0291
• Device Catalogue Number: 0291
• Device Lot Number: 5061711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other