MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER STAINLESS STEEL BLADES SIZE 15 STERILE; SCALPEL BLADE

Model Number 371215

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Aspen surgical received a report from our distributor indicating that a scalpel blade fell off of the handle and was left inside the patient after surgery.It then needed to be retrieved, in order to prevent any damage that the blade may cause.The scalpel blade was missing on closing count and could not be found.They allege that the blade fell off the handle when the surgeon extended the incision to retrieve the gallbladder our of the abdomen.Portable x-rays were done, and the scalpel blade was found.The patient was re-prepped with chlorhexidine and re-draped in sterile drapes.The scalpel blade was retrieved by the surgeon.Abdomen views via laparoscopic camera post removal and no obvious lacerations or bleeding were noted by the surgeon.The surgeon talked to the family about the incident, and started patient on additional doses of antibiotics.This incident is tracked in our complaint system as (b)(4).

Manufacturer Narrative

Aspen surgical received a report from our distributor indicating that a scalpel blade fell off the handle during a procedure, and was left in the patient.With the use of x-rays, the blade was found and retrieved from inside the patient.Surgeon confirmed no additional injury due to the blade being left in patient.The actual device is in process of being returned for evaluation.The manufacturing lot number was provided for review.Once the investigation is complete, if any additional relevant information is identified it will be included in a supplemental report.

• Brand Name: BARD-PARKER STAINLESS STEEL BLADES SIZE 15 STERILE
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 19164751
• MDR Text Key: 340838625
• Report Number: 3002750084-2024-00014
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371215
• Device Lot Number: 325313
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention