MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER CARBON RIB-BACK BLADES; BLADE, SCALPEL

Lot Number 0118976

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 03/02/2017

Event Type  malfunction  

Event Description

Surgical tech was loading the surgical blade into the knife handle before the case was to start and the blade shattered into three pieces.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt drive se; caledonia MI 49316
• MDR Report Key: 6518306
• MDR Text Key: 73588250
• Report Number: 6518306
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 0118976
• Other Device ID Number: DGW955101 P 8365408 SIZE 15 B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Weight: 63