MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS #15 BLADE; BLADE, SCALPEL

Device Problem Break (1069)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

Aspen surgical received medwatch report (b)(4), indicating that a #15 knife blade broke during a procedure.No injury/death was reported.This event was filed in our compliant handling system as number (b)(4).

Manufacturer Narrative

Aspen surgical received a medwatch report from the fda indicating that a #15 knife blade broke off while in use for a procedure.The actual device was not returned for evaluation.The item number and lot number were not provided, and could not be identified.No photographic evidence was provided.Upon follow-up with the initial reporter, they are unable to confirm any specific information about the device other than that it was a bard parker #15 blade.Based on the lack of any evidence being provided for evaluation, cause could not be identified.

• Brand Name: #15 BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: terry hall ; 6945 southbelt dr; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 18270221
• MDR Text Key: 330674613
• Report Number: 1836161-2023-00045
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2023

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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