MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER BLADE #15; BLADE, SCALPEL

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

#15 knife blade broke off while in use and extended surgical time with difficulty in retrieval of the piece broken off in patient wound.Physician stated he utilized minimal action in blade manipulation before the break.The patient had no post-op complications and is doing well.

• Brand Name: BARD-PARKER BLADE #15
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 18147847
• MDR Text Key: 328266149
• Report Number: 18147847
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White