MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER STAINLESS STEEL BLADES; BLADE, SCALPEL

Model Number 371211

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2024

Event Type  malfunction  

Event Description

From staff: doctor was operating and 11 blade went in, and he felt it break.Took knife handle out and then got the other piece out in a safe manner.Blade came out of patient and went to in a specimen container where it is being kept in the team lead office in the operating room.X-rays were taken and cleared by a radiologist.No equipment was being used in the wrong manner.From operative report: it was noted that the 11 blade had broken into 2 pieces.We could clearly visualize the entirety of the broken blade fragment at all times and did not lose visualization at all.The knife handle was removed.The remaining blade fragment was grasped through the lateral portal and then a snap brought in through the direct portal and this allowed us to cleanly and easily remove the knife blade.We brought the broken knife blade back to the back table and matched it up with the portion that had remained on the knife handle, and it was found to be a perfect match with no evidence of fragmentation.

• Brand Name: BARD-PARKER STAINLESS STEEL BLADES
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt drive s.e; caledonia MI 49316
• MDR Report Key: 19212063
• MDR Text Key: 341375513
• Report Number: 19212063
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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: 371211
• Device Catalogue Number: 371211
• Device Lot Number: 0342908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 4 KG