MAUDE Adverse Event Report: BARD-PARKER / BECTON DICKINSON #11 STAINLESS STEEL SURGICAL BLADE; BLADE, SCALPEL

Lot Number 0153052

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2018

Event Type  Injury  

Event Description

At the beginning of the left knee arthroscopy with menisectomy surgical procedure, the stainless steel surgical blade broke off in the pt's knee.At the end of the procedure, the surgeon had to make a large incision (2.5cm) and was able to retrieve the broken piece of the knife blade without any complications.

• Brand Name: #11 STAINLESS STEEL SURGICAL BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): BARD-PARKER / BECTON DICKINSON
• MDR Report Key: 7665729
• MDR Text Key: 113396032
• Report Number: MW5078255
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0153052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 105